clinical research associate resume examples

Clinical Research Associate Resume Examples and Templates for 2024

• Resume Examples
• Resume Text Examples

How To Write a Clinical Research Associate Resume

• Entry-level
• Senior-level

Clinical Research Associate Text-Only Resume Templates and Examples

Jessica Lang (123) 456-7890 [email protected] 123 Santa Maria, San Francisco, CA 12345

A Clinical Research Associate with entry-level experience, specializing in quality control, audits, continuous improvement, and GCP regulations. Adept at analyzing complex data sets and identifying opportunities to enhance the quality of clinical research initiatives.

Professional Experience

Clinical Research Associate, Arkline Pharmaceuticals, San Francisco, CA September 2021 – Present

• Wrote clinical trial documentation for a pharmaceutical company analyzing the efficacy of a new antidepressant, including consent forms, study protocols, and QC guidelines
• Ensure compliance with FDA, ICH, and GCP regulations, conduct study audits, develop SOPs, and identify opportunities to reduce protocol deviations
• Coordinate with research coordinators to ensure the accuracy and transparency of data

Clinical Research Internship, Solaris Biomedical, San Francisco, CA May 2021 – September 2021

• Provided support for the planning and execution of clinical studies under the direction of the CRA, including reviewing documentation and driving process improvements
• Ensured compliance with ethical and scientific standards for data collection and analysis

Bachelor of Science (B.S.) Clinical Research University of San Francisco, San Francisco, CA  September 2017 – May 2021

• Clinical Research
• GCP Regulations
• Clinical Trial Documentation
• Process Improvement
• Quality Control

Certifications

• Certified Clinical Research Associate (CCRA), ACRA, 2021

Skyler Thompson (123) 456-7890 [email protected] 123 Pine Brook Dr, Miami, FL 12345

A Clinical Research Associate with five years of experience, specializing in ensuring compliance with GCP, FDA, and ICH regulations. A strong history of building strategic partnerships and developing strategies to improve patient recruitment and retention.

Clinical Research Associate, Heart and Wellness Research Firm, Miami, FL September 2019 – Present

• Coordinate with multidisciplinary research teams to execute clinical trials for cardiology research, including patient enrollment, qualification visits, and site initiation visits
• Define strategies for patient recruitment, build strategic partnerships with healthcare organizations, and develop new recruitment channels, resulting in a 120% increase in patient retention and a 50% reduction in associated recruitment costs
• Establish new documentation review protocols to ensure GCP regulatory compliance and reduce delays associated with IRB compliance by 40%

Clinical Research Associate, St. John’s Medical Center, Miami, FL May 2017 – September 2019

• Identified investigators, led patient recruitment initiatives, performed site initiatives visits (SIV), and conducted pre-study activities for oncology clinical research trials
• Managed preparation of documentation for IRB submissions and patient enrollment, including study protocols, consent forms, and confidentiality agreements

Bachelor of Science (B.S.) Clinical Research University of Miami, Miami, FL September 2013 – May 2017

• Patient Recruitment
• Clinical Research Qualification
• Regulatory Compliance
• Clinical Studies
• Certified Clinical Research Professional (CCRP), SORCA, 2020
• Certified Clinical Research Associate (CCRA), ACRA, 2017

Mina Sayed (123) 456-7890 [email protected] 123 Carpenter Street, Philadelphia, PA, 12345

A Clinical Research Associate with five 10+ of experience, specializing in CTMS, EDMS, regulatory compliance, and SAE reporting. A proven track record of collaborating with multidisciplinary teams to execute complex clinical research initiatives.

Senior Clinical Research Associate, University of Pennsylvania, Philadelphia, PA September 2015 – Present

• Deliver research support for a series of clinical trials for the neurology department, including IRB submissions, patient recruitment, and the development of study protocols
• Utilize clinical trial management systems (CTMS) to coordinate project management functions of clinical trials, including patient tracking and study deviations
• Oversee Serious Adverse Event (SAE) reporting activities, including coordinating with the Principal Investigator to ensure transparency and accurate reporting of adverse events

Clinical Research Associate, Temple Hospital, Philadelphia, PA May 2012– September 2015

• Provided essential support for the execution of clinical research trials, which included creating documentation for IRB submissions and interfacing with sponsors through the duration of the trial lifecycle
• Ensured proper tracking and organization of patient visits, drug supply, and adverse events using electronic data capture (EDC) and clinical trial management systems (CTMS)

Bachelor of Science (B.S.) Clinical Research Temple University, Philadelphia, PA September 2008 – May 2012

• Serious Adverse Event (SAE) Reporting
• Clinical Trial Management Systems (CTMS)
• Electronic Data Capture (EDC)
• IRB Submissions
• Relationship Building
• Certified Clinical Research Coordinator (CCRC), 2016
• Certified Clinical Research Professional (CCRP), SORCA, 2014
• Certified Clinical Research Associate (CCRA), ACRA, 2012

To craft an impactful clinical research associate (CRA) resume, showcase your unique background supporting all aspects of clinical trials. Provide specific examples of you identifying opportunities to improve accuracy, transparency, and efficiency. Emphasize your comprehensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) regulations. This guide will provide expert tips to help you translate your career into an accomplishment-driven CRA resume.

1. Write a dynamic profile summarizing your clinical qualifications

Start your resume with a powerful opening summary that encapsulates your strongest qualifications as a CRA. List your title, years of experience, and three to four specializations in your opening sentence that match the job description. Highlight your expertise in regulatory compliance, patient recruitment, and data reporting for clinical trials. Illustrate your experience collaborating with multi-disciplinary teams to support research initiatives. Emphasize your passion for improving quality of life and driving positive patient outcomes through new clinical discoveries.

Senior-Level Profile Example

A CRA with 10 years of experience, specializing in clinical trial management system (CTMS), electronic document management system (EDMS), regulatory compliance, and SAE reporting. A proven track record of collaborating with multidisciplinary teams to execute complex clinical research initiatives.

Entry-Level Profile Example

A CRA with entry-level experience, specializing in quality control, audits, continuous improvement, and GCP regulations. Adept at analyzing complex data sets and identifying opportunities to enhance the quality of clinical research initiatives.

2. Add your clinical experience with compelling examples

Your professional experience section is the foundation of your resume, and it needs to feature your most compelling achievements to grab the attention of prospective employers. Highlight your contributions and the end results of your research studies. Incorporate key performance indicators (KPIs) to emphasize the success of your clinical trials and enhance the impact of your bullet points. Showcase examples of you implementing new strategies to drive patient recruitment and retention. Feature achievements that illustrate your experience reducing delays associated with internal review boards.

Senior-Level Professional Experience Example

Senior Clinical Research Associate, Heart and Wellness Research Firm, Miami, FL | September 2019 – present

• Coordinate with multidisciplinary research teams to execute clinical trials for cardiology research, including patient enrollment, qualification visits, and site initiation visits (SIV)
• Define strategies for patient recruitment, build strategic partnerships with health care organizations, and develop new recruitment channels, resulting in a 120% increase in patient retention and a 50% reduction in associated recruitment costs
• Establish new documentation review protocols to ensure GCP regulatory compliance and reduce delays associated with institutional review boards (IRB) compliance by 40%

Entry-Level Professional Experience Example

Clinical Research Associate, Arkline Pharmaceuticals, San Francisco, CA | June 2021 – present

• Wrote clinical trial documentation for a pharmaceutical company analyzing the efficacy of a new antidepressant, including consent forms, study protocols, and quality control guidelines
• Ensure compliance with FDA, ICH, and GCP regulations, conduct study audits, develop standard operating procedures (SOPs), and identify opportunities to reduce protocol deviations

3. Include clinical-related education and certifications

As a CRA, it is best to feature relevant education and industry certifications to show hiring managers you have the regulatory knowledge and experience to succeed in demanding clinical environments. While credentials are not always required, obtaining certifications can help you stand out in a competitive job market. The Certified Clinical Research Associate (CCRA) and Certified Clinical Research Professional (CCRP) designations are both strong options that demonstrate your advanced understanding of clinical research protocols and government regulations.

• [Degree Name]
• [School Name], [City, State Abbreviation] | [Graduation Year]
• Bachelor of Science (B.S.) Clinical Research
• Temple University, Philadelphia, PA | 2016
• [Certification Name], [Awarding Organization], [Completion Year]
• CCRP, SORCA | 2020
• CCRA, ACRA | 2017

4. Include a list of skills and proficiencies related to clinical work

Organizations utilize Applicant Tracking Systems (ATS) to identify qualified applicants based on specific keyword requirements. If your document lacks sufficient key terms, you may not advance to the next phase of the hiring process. Incorporating appropriate terminology is also important for making a positive impression on the hiring manager. Feature a mix of regulatory, clinical research, and leadership skills to stand out from the competition. Below, you’ll find a list of potential keywords you may encounter while pursuing CRA positions:

5. Feature clinical research reporting activities

Another essential aspect of a CRA role is ensuring proper clinical research data reporting throughout the trial. One of the most important types is an SAE, which involves reporting serious injuries, hospitalization, or death of a trial subject. Employers must see you have the expertise to support their organization with all their clinical reporting requirements. Feature your expertise in SAE reporting and CTMS, which research organizations have heavily adopted to centralize data reporting in recent years.

How To Pick the Best Clinical Research Associate Resume Template

When selecting your template, look for a clean, simple format that allows the hiring manager to scan your document for key pieces of information easily. Avoid cluttering your resume with flashy colors, graphics, and overly decorative fonts, as strong visual elements can often distract the reader from your content. Choose a well-organized, single-column template that allows you to deliver a smooth, sequential reading experience.

Frequently Asked Questions: Clinical Research Associate Resume Examples and Advice

What are common action verbs for clinical research associate resumes -.

Running out of action verbs when crafting your resume is easy. There are only a few words to describe your professional experience accurately. This can be especially challenging for health care or pharmaceutical professionals. To help you keep your content fresh and enhance the readability of your bullet points, use these action verbs to convey your work experience:

How do you align your resume with a clinical research associate job description? -

According to the Bureau of Labor Statistics , over 136,800 new openings are projected each year for life, physical, and social science occupations. Despite the above-average growth rate, align your resume with the job description to increase your odds of landing the interview. Carefully analyze each posting and incorporate regulations, clinical terminology, and keywords that match the organization’s research needs.

Showcasing your knowledge of regulatory compliance is important, but also emphasize soft skills. For example, you may want to provide insights into your ability to collaborate with diverse teams and third-party sponsors, as a CRA often interacts with various groups during the clinical trial lifecycle. Demonstrating that you possess the clinical research and communication skills to succeed in the role will help employers see you’re the right fit for their culture and long-term objectives.

What is the best clinical research associate resume format? -

Reverse chronological is the ideal resume format for CRAs. This allows you to place your most recent and relevant work experience towards the top of your document while demonstrating your career progression. At the entry level, you can opt for a combination format in lieu of a robust work history. This places your skills and academic projects above your professional experience but allows you to tell your story using detailed bullet points.

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Craft a matching cover letter to strengthen your job application. Carefully tailor your cover letter to each individual job application. Mention something specific about the organization’s mission statement, reputation, or research accomplishments and why this draws you to apply for the role. For more insights, visit our research assistant cover letter guide .

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Certified Professional Resume Writer (CPRW)

Frank Hackett is a professional resume writer and career consultant with over eight years of experience. As the lead editor at a boutique career consulting firm, Frank developed an innovative approach to resume writing that empowers job seekers to tell their professional stories. His approach involves creating accomplishment-driven documents that balance keyword optimization with personal branding. Frank is a Certified Professional Resume Writer (CPRW) with the Professional Association of Resume Writers and Career Coaches (PAWRCC).

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Clinical Research Associate Resume Samples

Clinical research associates are involved in collecting and organizing data that are obtained from trials and studies made from pharmaceuticals and biotechnology. Apart from coordinating the process results the clinical research associates are involved in disbursing such duties as – developing trial products , presenting trial protocols, designing data collection forms , liaising with investigators , monitoring the trail throughout the project, verifying data, setting up trial sets, writing visit reports, closing down trial sites and wiring technical trial reports for submission.

A well-drafted Clinical Research Associate Resume emphasizes on skills and qualifications such as – excellent communication skills, relationship building abilities, numeracy skills, and eye to details, multitasking skills, the ability to collect data and good IT skills. As this job involves documentation and recording tasks, candidates are supposed to have thorough computerized processing skills and understand the importance of clinical practices too. To become a CRA, candidates should have a degree or PG degree in life science, medical science, or nursing.

• Resume Samples
• Clinical Research Associate

Clinical Research Associate Resume

Summary : A driven and talented professional with an excellent track record in clinical research, seeking a challenging position in a research oriented organization, where I can apply my knowledge and expertise as well as contribute to the organization as a whole.

Skills : Ability to multi-task and think on your feet.

Description :

• Provides site management and monitoring support for sponsored clinical studies.
• Conduct Site Qualification, initiation visits, on-site monitoring visits, co-monitoring visits, and site closure visits of all phases of clinical trials Prepare site visit reports and provide assistance to site staff in resolving deficiencies.
• Educates and trains site and study staff in conduct and management of sponsored studies, including assurance to regulatory and ICH/ GCP compliance.
• Collects and processes regulatory documentation for investigational studies in compliance with required guidelines.
• Assist in the protocol, Informed Consent, and CRF design and review.
• Develops and demonstrate an understanding of and apply therapeutic area knowledge to assignments and project-related issues.
• Appropriately resolves issues related to trial monitoring and management with guidance from Project Manager.

Clinical Research Associate/Assistant Resume

Objective : A dedicated and goal oriented clinical research associate, creative thinker/problem solver, positive attitude providing solid academic credentials and cross functional experience in clinical project management, product knowledge, time management, organizational and process improvement.

Skills : Microsoft Office.

• Assisted the data management groups and the project team in the processing of all clinical data by ensuring the timely collection of other aspects of job-related responsibilities data and query resolution.
• Conducted site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
• Coordinated with investigators and site workers to ensure that the protocol is being adhered to while checking for Protocol deviations throughout the course of the study.
• Developed recruitment strategies and an enrollment plan with the investigator and site staff to meet recruitment goals in coordination with the SOP and GCP guidelines.
• Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
• Ensure Visit Reports are written and submitted via CTMS within 5 working days of visit.
• Participate in various sponsor/project team communication and training sessions Prepares for and attends Investigator Meetings Responsible for the evaluation of clinical data to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH/GCP Guidelines.
• Worked as an integral team member with respect to quality, integrity, timeliness, and cost effectiveness when monitoring Worked in conjunction with the in-house project teams to ensure that sites have adequate study drugs and supplies.

Lead Clinical Research Associate Resume

Objective : Clinical research associate & Medical school graduate with prior work experience spanning medical chart reviews, electronic data gathering and interpretation, documenting case report forms, computer data logging. Co-author on published research work. Qualified US medical licensing exams, completed required clinical research trainings. Strong computer skills.

• Responsible for the start-up, initiation, implementation and the management of clinical trials for the assigned sites.
• Monitor and provide site management oversight for assigned clinical trials (phase I- IV) according to ICH-GCP guidelines, FDA regulations, protocol and sponsor SOPs.
• Collaborate closely with the entire study team, including the medical Monitor, Project Manager, and the entire in-house study team to ensure the successful execution of the clinical study.
• Independently prepare and perform Investigator site visits relevant to the phase of the study including, site selection and qualification, initiation, regular monitoring or site closure visits as specified in the Project Plan and the Monitoring Guidelines.
• Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations.
• Report any findings related to the study to the Project Managers responsible for the respective studies.
• Review patient documents (informed consent, subject information sheet), clinical study protocol, CRF and trial related financial agreements as required to ensure compliance with the protocol and study guidelines.
• Ensure that Serious Adverse Events, IND Safety Alerts, Protocol Deviations and other safety related items are reported to the IRB to ensure that the subject's rights, safety and well-being are protected.

Sr. Clinical Research Associate Resume

Summary : Experienced multilingual Project Manager/ Associate Director professional with proven success in biopharmaceutical and medical device industries, leading multiple operational areas. Responsible for leading multiple operational areas of clinical trials to meet aggressive approvals.

Skills : Management, Customer Relationship Management, Human Resources, Hiring, Operations Management, Office Management, Team Building, Word.

• Managed startup and completion of activities associated with clinical research studies per CFR and ICH regulations and ISO requirements.
• Assisted in preparation of final study reports, statistical analysis plans, data management plans and other required reports leading to FDA approval and job promotion.
• Created, maintained and managed Trial Master Files for compliance Managed clinical project functions through weekly project team meetings, study performance metrics creation, review and management.
• Assisted in managing financial aspects of the project including CRO, vendor and site payments, tracking and processing of payments.
• Monitored and managed study sites, ensuring site's completion of regulatory activities and integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
• Enforced and ensured adherence to GCPs of all clinical sites.
• Participated in design and coordination of pre-clinical development projects, leading to future clinical trials and subsequent approval of new products.
• Evaluated and analyzed clinical studies in conjunction with Regulatory Affairs and Research and Development, resulting in design of new protocols and start of new clinical trials.

Jr. Clinical Research Associate Resume

Summary : Over 8 years experience in clinical research as a CRA, Regulatory Affairs, Study Coordinator, Project Manager and Data Manager with Phase I-IV studies.

Skills : Experience in clinical research with solid background in clinic medicine, and translational research.

• Assisted with development, management, site monitoring and implementation of clinical, behavioral and pharmaceutical trials while managing over 15 domestic and international sites in the NIH-funded HIV Prevention Trials Network.
• Primary Clinical Study: HPTN 064 The Women's HIV Seroincidnece Study Site management and site monitoring of ten clinical research sites via outbound telephone calls, web-based tools, and other communications tools to ensure compliance with the protocol requirements, study procedures and ICH/GCP/EMEA/FDA guidelines.
• Performed site activities including site initiation, sites selection, site/study monitoring and site/study closeout visits.
• Managed qualitative data and performed qualitative analysis using Nvivo 8.
• Assisted with writing manuscripts for journal submissions and abstracts for professional conferences.
• Monitored regulatory reviews including IRB, and participated in protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.
• Conducted literature reviews for manuscript planning and conducted orientation of additional qualitative staff.
• Developed study training materials and facilitated trainings with study team and sites as needed.

Clinical Research Associate III Resume

Summary : Consistently working to achieve or exceed management goals and objectives; excellent interpersonal and communication skills at all levels of the organization, with associates and patients; quickly adapt to new policies, procedures and protocols. Team player, dependable and reliable, service and quality oriented and readily handle multiple-tasks.

Skills : Clinical Research, Microsoft Windows, Office, Excel, Access, PowerPoint, Outlook.

• Coordinate with the collection, distribution, and storage of data obtained during clinical research trials, for the testing of drugs and medical products.
• Ensured that trials stay on track with clinical objectives and complies with federal regulations, analyze data, create comprehensive reports, make presentations and monitor individual cases.
• Performed CRF review; query generation and resolution against established data review guidelines data management systems.
• Ensure study staff conducting the protocol have received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements, as written.
• Identified and completed follow-up of Serious Adverse Events at assigned study sites.
• Ensured the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
• Ensure that the Site Regulatory Documents are complete and current through trial.

Clinical Research Associate II Resume

Objective : Seeking a CRA position where I can contribute to the success of clinical trials and drug development as a whole.

Skills : Research/Project Management expertise in Cardiology.

• Responsible for all aspects of site management from site selection to site close out.
• Involved in the investigator site identification process and performed site evaluation visits to ascertain site's capabilities and suitability to conduct the clinical trial.
• Site study start up activities including budgeting, contract development and negotiations, site initiation visits, and GCP Instruction to Investigators/Research Personnel.
• Managed the site regulatory submission process to ensure that all bottlenecks are ironed out and that delay of the clinical trial campaign is avoided.
• Conducted presentations and trained site personnel during Investigator Meetings.
• Performed ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.
• Performed troubleshooting and problem solving tasks at sites to help achieve turnaround results.
• Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists as required during the study.

Clinical Research Associate I Resume

Objective : 3 years of progressive experience working as Clinical Research Associate on Phase II, III clinical studies in the therapeutic areas of Cardiovascular, Endocrinology(Diabetes), and CNS, with strict adherence to ICH/FDA regulations. Clear communication and drive for results by site coordinators, investigators and vendor representatives. Ability to timely collect study documentation for TMF, reconcile inpatient and outpatient source data with electronic case report forms (eCRFs), and assist in resolving issued data queries.

Skills : Power point, Multitasking, Microsoft office, excel.

• Conducted routine monitoring and close-out visits at Investigative sites to assess protocol, regulatory and ICH-GCP compliance.
• Carried out site-initiation visits and ensured that all study materials such as updated protocols, investigator brochures, instructions and investigational product is received by the site.
• Trained the investigator and staff regarding Study protocol and conduct via presentations, informational handouts and group discussions, identified any study related issue and suggested corrective measures if any or escalated the issue to the Manager as needed.
• Ensured the subject enrollment, advertising for the study, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, scans etc.
• Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents and essential documents are forwarded to the sponsor for updating the TMF as necessary.
• Assured timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs).
• Documented all findings and activities at the site and complete a monitoring visit report and submit to the Manager.

Clinical Research Associate (Full Time) Resume

Headline : To obtain a position in the biotech/pharmaceutical industry where I can utilize my skills as detail oriented, motivated, strong communication, analytical and organizational skills for clinical research and medical advancement.

Skills : Biochemistry, Molecular Biology, PCR, Protein Purification, Cloning, Scientific Writing, Life Sciences, Clinical Monitoring.

• Responsible for reviewing and tracking of study essential documents (e.g., IRB approvals, 1572s, CVs, investigator licenses and board certifications, lab certifications and normal ranges, etc) to ensure completeness and accuracy.
• Verify and ensure proper storage/handling, accountability and distribution of investigational product and trial supplies.
• Review and track regulatory documents and the verification of data management queries to meet clinical study timelines.
• Monitor clinical studies in accordance with sponsor's protocol and GCPs to assess the safety and efficiency of investigational products.
• Applying FDA regulations and ICH-GCP guidelines to all aspects of clinical studies including but not limited to: protocol compliance, IRB submissions, ICF review, handling adverse events to ensure safety and protection of study participants and enhanced data credibility.
• Track and monitor enrollment at sites, initiating additional recruitment and retention strategies as required.
• Manage time effectively in order to fulfill requirement to meet all timelines, in both therapeutic work and submission of administrative documents.

Clinical Research Associate/Coordinator Resume

Summary : Clinical research professional with a background in chemical biology research in anticancer and antibiotic drug development using biotechnology. I thrive on change that is the foundation for improvement.

Skills : Clinical Research Monitoring/Mgt, Data Management, Regulatory.

• Participate in site pre-study, initiation, routine monitoring, and study closeout visits in-line with SOPs and Protocols.
• Compile reports to quality standards within company specified timelines.
• Provide quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
• Conducting monitoring visits as needed, to assert protocol adherence; conduct source verification; verify drug accountability and storage requirements; and ensure compliance with regulatory requirements and SAE/AE reporting requirements.
• Collect, review, track, and ensure appropriate completion of site-specific study/essential documents.
• Performs ongoing reconciliation of the Trial Master Files (TMF) content to site files.
• Creating, maintaining, and reviewing monitoring standard operating procedures, monitoring tools for conducting monitoring tasks including: monitoring plans, monitoring reports, corrective and preventive action plans.
• Conduct training for investigative site personnel on study protocols and visit procedures Acts as primary liaison for assigned study sites while to convey project information.

Clinical Research Associate/Analyst Resume

Objective : An adaptable high-achiever and result-oriented research professional with almost 3 years of on-site clinical research experience and 16 months of progressive monitoring as a CRA with a career record spanning all aspects of management, execution, training organizing, setting up and implementing systems for getting tasks completed. Experienced in monitoring multiple site locations, in accordance with GCP and Sponsor SOP's.

Skills : In-depth knowledge of clinical research procedures,.

• Conduct monitoring visits to perform on-site review of files and records for source document verification and review of case report forms for completeness, accuracy, consistency and Protocol compliance.
• Perform drug accountability to ensure adequate storage, dispensing and use of investigational product at the site.
• Conduct pre-study visits to evaluate the suitability of investigational sites for the investigation study and ensured the availability of facilities, resources, and qualified and experienced personnel.
• Review Serious Adverse Event (SAE) reports and ensured that appropriate reporting procedures were performed within the required time frame.
• provide on-going instruction to research site personnel, as necessary, on proper conduct of the trial.
• Perform routine monitoring visits according to the monitoring plan to ensure site adherence to protocol and all study guidelines.
• Conduct initiation visits to open up investigational sites for clinical studies and ensured the investigational product has been received and that all study supplies and equipment have been received and ready for the commencement of the study.

Summary : Devoted Clinical Research Associate who is very detail-oriented. Comprehensive background includes being a Clinical Research Associate for over a year and Certified Pharmacy technician for over ten years. Experienced in implementing Standard Operating Procedures and Good Clinical Practices.

Skills : Aspectic Technique.

• Travel performing on-site monitoring visits, including site selection, site initiation, periodic, close out and corrective action visits.
• Independently performs monitoring activities for multiple sites and multiple projects, identifying deviations from regulations and SOPs.
• Evaluates protocol and regulatory compliance, including source document verification, informed consent process, human subject protection, data integrity, drug accountability, compliance, review of investigator and regulatory files.
• Provides study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations.
• Identify action items, subject safety, data integrity issues and retrain site personnel accordingly.
• Communicates routine and unusual findings to trial supervisor.
• Independently documents routine site management and ongoing follow-up, clinical monitoring activities, site communication and trial related activities.
• Provides knowledge of protocol, study documents and processes, during monitoring activities.

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Clinical Research Associate Resume Examples

Writing a great clinical research associate resume is important because it is one of the first things a potential employer will see when they are considering you for a position. It is your opportunity to make a good first impression and sell yourself as the best candidate for the job.

Create your resume Select from 7 professional resume templates

If you're looking for inspiration when it comes to drafting your own clinical research associate resume, look no further than the samples below. These resumes will help you highlight your experience and qualifications in the most effective way possible, giving you the best chance of landing the clinical research associate job you're after.

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Essential Components of a Clinical Research Associate Resume

A Clinical Research Associate (CRA) plays a pivotal role in the healthcare industry, ensuring the smooth and ethical progression of clinical trials. Crafting a robust CRA resume is crucial to demonstrate your expertise, work history, and commitment to prospective employers. Your resume should not only detail your previous employment but also highlight your capacity to manage significant responsibilities, adhere to regulations, and collaborate effectively with diverse teams. This guide will dissect the critical elements of a Clinical Research Associate resume, providing insights into each section's significance and content, along with tips to enhance your resume's impact.

1. Contact Information

Contact Information is a fundamental section for a Clinical Research Associate (CRA) resume. It's the gateway for hiring managers to initiate contact, so accuracy and currency are paramount. Ensure your contact details are prominently displayed and error-free to facilitate smooth communication for interview arrangements or further discussions.

Typically, your Contact Information should include your full name, address, phone number, and a professional email address. Opt for an email that reflects professionalism, often a variation of your first and last names.

Consider adding your LinkedIn profile , personal website, or portfolio if they provide additional value to your application. However, these are supplementary and should only be included if they strengthen your candidacy.

Important: Avoid including sensitive personal information such as your social security number or driver's license number at this stage of the application process.

In essence, the Contact Information section is vital for facilitating communication between you and potential employers, so ensure it's clear, accessible, and contains all necessary details.

2. Professional Summary or Objective Statement

The Professional Summary or Objective Statement is a prominent feature of a Clinical Research Associate (CRA) resume. It's often the first section hiring managers encounter, so it must be compelling, concise, and tailored to the position you're targeting.

In the Professional Summary, showcase your core competencies, experiences, and notable achievements in clinical research. This is your opportunity to highlight your expertise in areas such as:

• Conducting clinical trials
• Data collection and analysis
• Regulatory compliance
• Patient recruitment
• Other relevant expertise.

Utilize this section to demonstrate your proficiency with Good Clinical Practice (GCP) guidelines or your familiarity with specific clinical data management systems.

For those new to the field or transitioning into clinical research, an Objective Statement may be more appropriate. Here, you can articulate your career objectives and how you intend to contribute to the organization, showcasing your enthusiasm and readiness to embrace new challenges.

Whether you opt for a Professional Summary or Objective Statement depends on your career stage.

• Your summary or statement should be precise and focused, emphasizing what you bring to the table as a potential CRA.
• Given that hiring managers often skim resumes due to time constraints, ensure this section captures their attention immediately by demonstrating your suitability for the role.

Further Reading: Top Clinical Research Associate Resume Objective Examples

3. Education and Certifications

The " Education and Certifications " section is a cornerstone of a Clinical Research Associate (CRA) resume, showcasing your academic background and professional qualifications, which are crucial in this field.

Employers typically require a minimum of a bachelor’s degree in life sciences or related fields such as biology, nursing, biochemistry, or pharmacy. Possessing a master's degree or Ph.D. can significantly enhance your employability and distinguish you from other candidates.

Certifications are highly regarded in the clinical research arena. The Association of Clinical Research Professionals (ACRP) offers the Certified Clinical Research Associate (CCRA) credential, signifying expertise in overseeing clinical trials. Similarly, the Society of Clinical Research Associates (SoCRA) provides the Certified Clinical Research Professional (CCRP) certification to individuals who meet specific criteria and pass an examination.

Include any relevant training courses you've completed, such as Good Clinical Practice (GCP) training, which is often a requirement due to its standardization of clinical trial conduct involving human subjects.

List your educational achievements starting with the most recent, including the institution's name and graduation year. For certifications, mention the title, issuing organization, and validity period, if applicable.

Effectively presenting your education and certifications can underscore your commitment to continuous learning and adherence to industry standards—attributes highly sought after by employers in a CRA candidate.

Further Reading: Clinical Research Associate Certifications

4. Relevant Work Experience

Your Clinical Research Associate (CRA) resume should emphasize your relevant work experience prominently. This section provides potential employers with a comprehensive view of your previous roles and responsibilities in clinical research, affirming your capability to excel in the position.

Focus on positions that have equipped you with the skills and knowledge pertinent to a CRA role. You may have previous experience as a Clinical Trial Assistant, Research Coordinator, or Research Nurse .

For each role listed, provide specific details about your responsibilities and accomplishments. For instance, if you coordinated clinical trials, mention the trial phases (I-IV), the number of sites managed, the therapeutic areas (such as oncology or cardiology), and key tasks like data collection, patient recruitment, or regulatory document management.

• Highlight any experience across various medical specialties or managing studies in multiple regions to demonstrate adaptability.
• Emphasize any familiarity with different study designs and methodologies.

It's crucial to show your knowledge of Good Clinical Practice (GCP) guidelines and other regulatory standards. If your work has been audited or inspected by regulatory bodies like the FDA or EMA, include these experiences as well.

Quantifying your achievements can make them more impactful . For example: "Oversaw 5 clinical trials concurrently across 10 sites" or "Achieved 100% compliance in all regulatory audits."

If you're new to the field but possess transferable skills from other healthcare or research roles that are applicable to a CRA position, be sure to highlight these experiences. Skills in patient care, data analysis, project management, or regulatory affairs can be highly relevant.

In summary, the 'Relevant Work Experience' section is where you can demonstrate your practical understanding of clinical research operations and your ability to manage the multifaceted responsibilities of a CRA.

5. Skills and Competencies

The " Skills and Competencies " section is a critical part of a Clinical Research Associate's (CRA) resume, showcasing the abilities you bring to the role. This section should highlight both hard and soft skills that qualify you for the position.

• Clinical Trial Management: CRAs must have a thorough understanding of the clinical trial process.
• Data Management: Proficiency in collecting, handling, and interpreting data is crucial.
• Regulatory Knowledge: Familiarity with GCP, FDA regulations, and other guidelines is essential.
• Medical Terminology: Knowledge in medical terminology, pharmacology, or related areas is beneficial.
• Technical Proficiency: CRAs often utilize specialized software for data collection and analysis.
• Communication Skills: CRAs must communicate effectively with various stakeholders, including doctors, patients, and sponsors.
• Attention to Detail: Precision is critical in clinical trials to ensure accuracy and compliance.
• Problem-Solving: CRAs must be adept at quickly identifying and resolving issues during trials.
• Organizational Skills: Managing multiple tasks simultaneously requires excellent time management and organizational abilities.
• Ethical Judgment: Upholding patient safety in clinical trials necessitates strong ethical decision-making.

Listing these skills on your resume can demonstrate your readiness for the role. However, it's also crucial to provide real-world examples of how you've applied these skills, allowing potential employers to envision how you could positively impact their team. Related: Clinical Research Associate Skills: Definition and Examples

6. Research Projects and Publications

The " Research Projects and Publications " section is an integral part of a Clinical Research Associate (CRA) resume. It allows you to showcase your practical experience and theoretical knowledge in the field.

Detail the research projects you've been involved in, starting with the project title, followed by a brief description of its objectives. Highlight your specific role, focusing on your responsibilities and any methodologies you utilized. If your involvement in a project led to significant findings or advancements in the field, emphasize these outcomes.

Publications are also a critical aspect of this section. If your research has been published in scientific journals or presented at conferences, list these accomplishments, including the title, publication or conference name, and date. Where possible, provide a link to the publication.

Quality is more important than quantity; it's better to thoroughly describe a few significant projects and publications rather than list many with minimal detail.

By effectively showcasing your research projects and publications, you can demonstrate not only your expertise and skills but also your commitment to advancing the field of clinical research—a trait highly valued by employers.

7. References or Affiliations

References: The "References" section of your Clinical Research Associate (CRA) resume is crucial. It provides potential employers with contacts who can vouch for your competencies, experience, and work ethic. These references should ideally be former supervisors, colleagues, or collaborators who are well-acquainted with your CRA-related work and can provide detailed insights into your capabilities. Always secure permission before listing someone as a reference.

Affiliations: The "Affiliations" section demonstrates your engagement with the clinical research community and your commitment to professional development. Membership in organizations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA) indicates your dedication to upholding industry standards and best practices.

Certifications: Include any relevant certifications from these professional bodies or other recognized institutions in this section. Credentials like the Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP) highlight your specialized expertise and skills.

Considerations:

• Customize this section for each job application to ensure relevance.
• Only include references and affiliations that are pertinent to the position you are applying for.
• Your aim is to present yourself as a knowledgeable, active participant in the clinical research community, recognized by peers for your contributions and proficiency.

Related Resume Examples

• Clinical Research Assistant
• Clinical Research Nurse
• Clinical Research Coordinator
• Clinical Research Manager
• Clinical Researcher
• Clinical Trial Associate

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5 Amazing clinical research associate Resume Examples (Updated 2023) + Skills & Job Descriptions

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Clinical research associate: resume samples & writing guide, employment history.

• Assist in the preparation of informed consent documents
• Assist with the selection, initiation, and training of clinical sites
• Monitor clinical trial sites to ensure compliance with protocol and overall clinical objectives
• Review clinical study protocols and related documents
• Participate in the development of clinical trial plans and strategies
• Maintain regulatory binders and files
• Develop and maintain positive relationships with clinical investigators and site staff
• Review and track case report forms for accuracy and completeness

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Professional Summary

• Assist with data entry and data management activities
• Participate in investigator meetings, teleconferences and site initiation visits
• Assist with preparation of clinical study reports
• Assist with preparation of study-related materials
• Prepare, review and track regulatory documents
• Assist with the development of study budgets and contracts

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Table of Content

• Introduction
• Resume Samples & Writing Guide
• Resume Example 1
• Resume Example 2
• Resume Example 3
• Resume Example 4
• Resume Example 5
• Jobs Description
• Jobs Skills
• Technical Skills
• Soft Skills
• How to Improve Your Resume
• How to Optimize Your Resume
• Cover Letter Example

clinical research associate Job Descriptions; Explained

If you're applying for an clinical research associate position, it's important to tailor your resume to the specific job requirements in order to differentiate yourself from other candidates. Including accurate and relevant information that directly aligns with the job description can greatly increase your chances of securing an interview with potential employers. When crafting your resume, be sure to use action verbs and a clear, concise format to highlight your relevant skills and experience. Remember, the job description is your first opportunity to make an impression on recruiters, so pay close attention to the details and make sure you're presenting yourself in the best possible light.

clinical research associate

• Responsible for the detailed processes of recruitment, including consenting, application of medical device, and collection of data.
•  Ensure integration of device  with EEG, other respiratory, cardiac and additional biological data collected during in-patient period and to make data set available to research team.
•  Enter data into relevant databases and prepare cohorts for in-house studies.
•  Undertake statistical analysis of data. 
• Maintain accurate and complete records and ensure data security and confidentiality of medical data. 
• Ensure the highest standard of record keeping, maintaining 
• Conduct research to develop methodologies, instrumentation, and procedures for medical application, analyzing data and presenting findings to the scientific audience and general public.
• Write and publish articles in scientific journals.
• Consult with and advise physicians, educators, researchers, and others regarding medical applications of physics, biology, and chemistry.
• Teach principles of medicine and medical and laboratory procedures to physicians, residents, students, and technicians.
• Design research studies in collaboration with physicians, life scientists, or other professionals.
• Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.
• Collaborate with others in the organization to ensure successful implementation of chosen problem solutions.

clinical research associate (oncology)

• Ensured safe and right conduct of clinical trials according to ICH-GCP guidelines. Maintained understanding of PPD’s SOP (standard operating procedures) and also required PPD SOPs Provided clinical study progress reports to Clinical Trial Manager periodically. 
• Planned & conducted pre-study site evaluation visits with Sr. Clinical Research Associates / Clinical Trial Monitor. Conducted clinical site feasibility and also help CTMs in study feasibility. Prepared and maintained Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents.
• Prepared EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation. Attended and assisted with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
• Planned & executed SIV (site initiation visit) with Sr. Clinical Research Associate/CTM. During site initiation visit (SIV) my responsibilities were meeting with clinical investigators (PI) and their teams to make sure that all aspects of the study were understood by the principal investigator and his/her staff, validated the suitability of the EC/IRB & to ensure that all records required for the study were completed.
• Managed the clinical central laboratory in regard to issues of site. Planned, conducted site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee. Closely kept track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development. Assessed the subjects (patients) for study protocol compliance though SDV (source data verification). Monitored patient Informed Consent progression for clinical study. Examined on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
• Identified discrepancies in the case report forms against the source documents occasionally, resolved them and after that took away the CRFs. Followed up with clinical site for resolution of DCFs or any queries. Ensured that adverse event/serious adverse event AE/SAE were reported and followed up with the concern departments. 
• Assessed appropriate Investigational Product (IP) answerability at site. Planned and conducted site close out visits (SCV) and made sure that collection of all clinical study data was completed. Prepared the applicable site visit reports and follow up letters. Subsequent to study completion, ensured that investigational products (IP) of the study were returned to the PPD.
• Participating in the site selection process, feasibility assessment; 
• Performing all types of study site monitoring visits;
• CRF review and source data verification; 
• Preparation for study submission to the regulatory authorities; 
• Site management; visit reporting; 
• S/AE processing, reporting and follow-up; 
• Ensuring on-site compliance with national regulations, GCP, protocol and procedures; 

sr. clinical research associate

• Conducting  pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP;
• Site management for assigned sites including written and verbal communication and scheduling of monitoring visits; 
• Preparation of visit reports and maintenance of study-related databases;
• Taking over Lead CRA responsibilities on a project, acting as the primary contact for all monitoring- related questions for the monitoring team;
• Facilitating training for new CRAs. 

clinical research associate Job Skills

For an clinical research associate position, your job skills are a key factor in demonstrating your value to the company and showing recruiters that you're the ight fit for the role. It's important to be specific when highlighting your skills and ensure that they are directly aligned with the job requirements, as this can greatly improve your chances of being hired. By showcasing your relevant skills and experience, you can make a compelling case for why you're the best candidate for the job.

How to include technical skills in your resume:

Technical skills are a set of specialized abilities and knowledge required to perform a particular job effectively. Some examples of technical skills are data analysis, project management, software proficiency, and programming languages, to name a few. Add the technical skills that will get hired in your career field with our simple-to-use resume builder. Select your desired resume template, once you reach the skills section of the builder, manually write in the skill or simply click on "Add more skills". This will automatically generate the best skills for your career field, choose your skill level, and hit "Save & Next."

• Data Analysis
• Quality Assurance
• Troubleshooting
• Database Management
• Clinical Research
• Regulatory Compliance
• Statistical Analysis
• Clinical Trials
• Protocol Development
• Project Management
• Risk Assessment
• Laboratory Techniques
• Data Collection
• Scientific Writing
• GCP Guidelines
• Electronic Data Capture
• Data Validation
• Medical Terminology
• Good Documentation Practices
• Study Management.

How to include soft skills in your resume:

Soft skills are non-technical skills that relate to how you work and that can be used in any job. Including soft skills such as time management, creative thinking, teamwork, and conflict resolution demonstrate your problem-solving abilities and show that you navigate challenges and changes in the workplace efficiently. Add competitive soft skills to make your resume stand-out to recruiters! Simply select your preferred resume template in the skills section, enter the skills manually or use the "Add more skills" option. Our resume builder will generate the most relevant soft skills for your career path. Choose your proficiency level for each skill, and then click "Save & Next" to proceed to the next section.

• Communication
• Interpersonal
• Time Management
• Problem Solving
• Decision Making
• Critical Thinking
• Adaptability
• Organization
• Public Speaking
• Negotiation
• Conflict Resolution
• Attention to Detail
• Self-Motivation
• Stress Management
• Collaboration
• Strategic Thinking
• Emotional Intelligence
• Flexibility
• Reliability
• Professionalism
• Computer Literacy
• Customer Service
• Presentation
• Written Communication
• Social Media
• Supervisory
• Risk Management
• Documentation
• Financial Management
• Visualization
• Business Acumen
• Process Improvement
• Relationship Management.

How to Improve Your clinical research associate Resume

Navigating resume pitfalls can mean the difference between landing an interview or not. Missing job descriptions or unexplained work history gaps can cause recruiters to hesitate. Let's not even talk about the impact of bad grammar, and forgetting your contact info could leave your potential employer hanging. Aim to be comprehensive, concise, and accurate.

• Assist with the development of study-related materials, such as training materials and manuals

Unexplained Year Gaps and Missing Job Experiences are a No-no

Gaps in your resume can prevent recruiters from hiring you if you don't explain them..

• It's okay to have gaps in your work experience but always offer a valid explanation instead of just hiding it.
• Use the gap to talk about positive attributes or additional skills you've learned.
• Be honest and straightforward about the gap and explain it using a professional summary.

How to Optimize Your clinical research associate Resume

Keep an eye out for these resume traps. Neglecting to detail your job roles or explain gaps in your career can lead to unnecessary doubts. Grammar blunders can reflect negatively on you, and without contact information, how can employers reach you? Be meticulous and complete.

• Develp & maintain positve relationships with clinical investigaters & site staff
• Assit with the develpment of study-related materials, such as training materials & manuels
• Review clinical study protocols & related documnets.
• Assist in the preperation of informed consent documents
• Prepare, reviw and track regulatory documents
• Review and track case report forms for accuracey and completness
• Assist with the selection, initiation, and trainning of clinical sites
• Review and track case report forms for accurracy and completeness.

Avoid Spelling Mistakes and Include your Contact Information

Missing contact information prevents recruiters from understanding you're the best fit for the position..

• Make sure you're not missing contact information on your resume. That should include your full name, telephone number and email address.
• Make sure to use a professional email address as part of your contact information.
• Highlight your contact information and double check that everything is accurate to help recruiters get in touch with you.

clinical research associate Cover Letter Example

A cover letter can be a valuable addition to your job application when applying for an clinical research associate position. Cover letters provide a concise summary of your qualifications, skills, and experience, also it also gives you an opportunity to explain why you're the best fit for the job. Crafting a cover letter that showcases your relevant experience and enthusiasm for the Accounts Payable role can significantly improve your chances of securing an interview.

Esteemed University of California Hiring Team

I am writing to express my interest in the Chief Clinical Research Associate role at University of California. As a Clinical Research Associate with 10 years of experience, I am confident that I possess the necessary skills and qualifications to excel in this position.

My life experiences have taught me the importance of hard work, dedication, and collaboration. Whether it was on the work, or just personally, I have always been committed to pursuing my goals with passion and tenacity. I am confident that throughout all of these years I have gained the skills and expertise necessary to succeed in this role and be a great asset for University of California. I am eager to join a team that shares my values and work towards a common goal.

Thank you for considering my application for the Chief Clinical Research Associate role. I am very passionate about this field and possess a deep understanding of the industry so, I am thrilled about the opportunity to contribute to your organization's success.

Showcase your most significant accomplishments and qualifications with this cover letter. Personalize this cover letter in just few minutes with our user-friendly tool!

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Clinical Research Associate Resume Sample

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Work Experience

• Perform management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines
• Create phone scripts, questionnaires, and other assessment tools for use in the selection of sites
• Assist team in the development of site recruitment and retention strategy
• Initiate contact with Principal Investigators (PIs), schedule an conduct pre-visits, assess potential investigators and recommend suitability of the site
• Assesses data generated by R&D/Business Teams
• Assists Regulatory in preparing responses to regulatory agencies’ questions regarding the clinical study
• Serves as key contact to assigned clinical sites throughout the study process
• Perform monitoring visits according to monitoring plan (including qualification visits, study initiation, training and closeout activities)
• Point of contact for sites and facilitator of communication between sites and key Edwards line functions
• Guide and support investigational sites on assigned projects
• Ensure preparation, collection and distribution of study master file documents
• Set up and ensure maintenance of investigator site file
• Timely write-up of study monitoring visit reports
• Support investigator in implementing appropriate contingency plans as needed
• Accountable for achieving and reporting on agreed clinical milestones
• Support study team in the interactions with Ethics Committees and Competent Authorities
• Participate actively to project team meetings, as required
• Assure continual compliance with ISO 14155 and Edwards SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, accountability and other tasks as specified
• Resolve deviations to standard through remedial action and training
• Escalate any issues regarding study conduct to his/her manager as needed
• Provide information and documents for Data review, safety reporting and complaint handling, if required
• Supports training and mentor of new hire, if applicable
• Interface with CPM as necessary for successful trial execution. Support CPM in creation and preparation of appropriate study management tools
• Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled

Professional Skills

• Excellent written and verbal communication skills, presentation skills, interpersonal skills, and analytical skills are required
• Strong communication skills, good presentation, negotiation and influencing skills
• Effective written and verbal English communication skills, strong oral presentation; interpersonal, decision making and issue resolution skills
• Professional collaboration skills, adept at influencing others and excellent communication skills
• Strong planning and organizational skills and the ability to work effectively and efficiently in adynamic environment with competing projects and deadlines
• Demonstrated initiative and excellent organizational skills in planning and executing study logistics
• Excellent oral and written communication skills. Ability to develop strong rapport with investigators and site staff

How to write Clinical Research Associate Resume

Clinical Research Associate role is responsible for english, interpersonal, organizational, computer, clinical, research, monitoring, technical, microsoft, organization. To write great resume for clinical research associate job, your resume must include:

• Your contact information
• Work experience
• Skill listing

Contact Information For Clinical Research Associate Resume

The section contact information is important in your clinical research associate resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

• First and last name
• Telephone number

Work Experience in Your Clinical Research Associate Resume

The section work experience is an essential part of your clinical research associate resume. It’s the one thing the recruiter really cares about and pays the most attention to. This section, however, is not just a list of your previous clinical research associate responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular clinical research associate position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Clinical Research Associate resume experience can include:

• Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
• Good analytical and assessment skills, judgement, and problem solving skills
• Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders
• Use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
• Well organized, with good time management and prioritizing skills
• Demonstrated ability in positive relationship building, with strong verbal and written skills

Education on a Clinical Research Associate Resume

Make sure to make education a priority on your clinical research associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your clinical research associate experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

• School you graduated from
• Major/ minor
• Year of graduation
• Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Clinical Research Associate Resume

When listing skills on your clinical research associate resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical clinical research associate skills:

• Excellent communication skills, including the ability to understand and present technical information effectively
• Effectively communicate using oral and written skills
• Demonstrates above average ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Demonstrate the ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Excellent computer skills and experience with MS Office programs
• A good team player, with strong inter-personal skills

List of Typical Experience For a Clinical Research Associate Resume

Experience for senior clinical research associate resume.

• Good oral and written communication skills, computer skills and experience with various data collection software
• Effective time management skills. Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Excellent communication skills: written, verbal and presentation skills required
• Strong collaboration, co-creation and influencing skills demonstrated across different levels, functions and geographies
• Good IT skills in, e.g. MS Office, are essential, for planning, tracking, communicating and reporting
• Strong organizational and project management skills; - ability or aptitude to provide solutions and contingency plans through the comprehensive
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability
• Excellent oral and written communication skills, self-motivated, highly organized, and able to work independently in a fast-paced research environment

Experience For Lead Clinical Research Associate Resume

• Excellent computer skills (Microsoft Office Word, Excel, Outlook) required
• Effectively prioritizes work to meet deadlines
• Able to multi-task under limited direction and on own initiative. Strong communication and inter-personal skills
• Excellent written, listening, and verbal communication skills
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
•  Good organizational and problem-solving skills
• Strong communication (verbal and written), negotiation and influencing skills
• Demonstrated computer skills (Word, Excel, PowerPoint, Outlook)

Experience For Clinical Research Associate, Dermatology Resume

• Demonstrates leadership skills, self-motivated and adaptable to a dynamic environment
• Driven self-starter with excellent self-management skills
• Solid interpersonal communication skills, both verbal and written
• Set and effectively communicate priorities in a dynamic environment
• Good coordination, organization and communication skills
• Demonstrate successful implementation of time management skills
• Strong organizational skills and attention to details required
• Able to work within teams and independently. Good interpersonal skills
• Good organizational, interpersonal and problem-solving skills

Experience For Lead Clinical Research Associate Amea Resume

•  Strong written and verbal communication skills in applicable languages, and business level command of English
• Good written and verbal communication skills. Written and verbal fluency in
• Excellent organizational skills. Ability to manage time and work independently
• Strong interpersonal skills, ability to establish and promote positive business relationships,customer service oriented
• Effective leadership and cross-functional skills within a team

Experience For Associate Clinical Research Associate Resume

• Monitoring experience in clinical research or other Clinical research experience
• Exhibit competencies in analytical/decision making, planning/priority setting, effective communication, and driving innovation
• Language Skills Required: Speaking - English and Local Language; Writing/Reading: English and Local
• Language Skills Required: Speaking - English and Local Language; Writing/Reading: English and Local Language
• At least 12 months on-site monitoring experience, ideally including experience monitoring clinical trials in Australia or New Zealand

Experience For Field Clinical Research Associate, Spain Resume

• At least 12 months of on-site monitoring experience, including experience monitoring clinical trials in Australia or New Zealand
• Prior experience writing SOP’s, performing gap analyses of SOP’s to prepare for FDA audits
• BS or RN and 2 years of clinical research experience, some of which includes on-site clinical research monitoring experience
• Basic molecular biology research skills, including nucleic acid purification and manipulation
• Prepare and complete monitoring visit reports and letters, and effectively document site communications per the CMP
• Study design, planning, coordination, completion and analysis which provides the highest level of scientific evidence and effective outcomes
• Proven track record of developing strong relationships with internal and external stakeholders

Experience For Clinical Research Associate, Istanbul Resume

• Communicate and coordinate effectively with research teams and HSPB colleagues
• Experience in Clinical Research with progressive experience working in clinical trials
• Proven record of being customer driven and providing effective consultation and training
• Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records
• Prior experience performing study start up activities (site qualifications, site initiations)

Experience For Clinical Research Associate, Korea Resume

• Work closely and effectively with all other department colleagues to ensure appropriate communication and study contact
• Knowledge and Skills in medical device and IVD industry, GCP and new product development
• A high level of both verbal and written communication skills
• Medical device industry experience as a CRA or experience in the medical device industry in either Clinical or Regulatory Affairs desired
• Communicate experimental results effectively in oral/written ways

Experience For Clinical Research Associate, Melbourne Resume

• Planning skills; ability to create and track detailed project plans
• Some prior Clinical Research Associate experience in Oncology
• Demonstrated effectiveness in resolving site management issues of varying complexity
• Experience hands-on clinical research experience encompassing all aspects of the clinical process, including
• Previous clinical research experience, including 2+ years of clinical site monitoring experience
• Strong experience managing early to late phases clinical studies and working with CROs and other study vendors
• Analyze,evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills

Experience For Clinical Research Associate Cra-norway Resume

• Strong working knowledge of Good Clinical Practices (GCP) and FDA regulations related to clinical research
• Desired 4+ years experience in clinical research or having demonstrated adequate level of proficiency within the CRA II competency profile
• Experience in clinical research (monitoring) required, with experience in all stages of study lifecycle (start-up, recruitment and close out)
• Previous monitoring experience would be a strong asset
• Experience of clinical study monitoring or equivalent experience in the clinical research field is an asset

List of Typical Skills For a Clinical Research Associate Resume

Skills for senior clinical research associate resume.

• Demonstrated excellent written, verbal and organizational skills. Demonstrated ability to prioritize work, meet deadlines, and maintain accurate records
• Strong verbal and written communication skills and good interpersonal/group skills
• Excellent communication skills to effectively interact with all levels of administration and health care team
• Advanced verbal and written communication skills, in addition to excellent organizational skills and management of cross-functional teams
• Strong organization skills and ability to communicate effectively with and present to cross-functional groups
• + Good computer skills with good working knowledge of a range of computer packages

Skills For Lead Clinical Research Associate Resume

• Excellent communication and team work skills – in order to establish good communication line between PPD and the site
• Excellent communication skills (both written and oral) and the ability to build effective relationships
• Highly developed verbal and written communication skills, time management, and organizational skills
• Leadership and management skills to effectively assist with management of CROs and other vendors
• Proven interpersonal, leadership, organizational and effective time management skills
• Leadership skills, influence management and collaboration skills

Skills For Clinical Research Associate, Dermatology Resume

• Partnering with product managers to develop priority lists for clinical evidence and develop timelines for delivery of evidence
• Demonstrated ability to assist in the growth and development of project team members through mentoring and coaching and exhibiting leadership skills
• Strong organizational, writing and communication skills. Ability to prepare accurate, thorough and complete documents, including monitoring reports
• Strong organizational skills to cope with multi-tasking which result in a goal oriented approach without losing the attention to details
• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with competing projects and deadliness
• Strong working knowledge of ICH/GCP regulations and monitoring skills
• Demonstrate complex problem solving, decision making and communication skills
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Delete
• Excellent communication, interpersonal, decision making/problem solving and organizational skills

Skills For Lead Clinical Research Associate Amea Resume

• People management skills: good communicator in writing and verbally with the ability to speak assertively
• Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and close-out)Demonstrated leadership skills
• Excellent writing skills and attention to project details
• Excellent computer skills, including proficiency with all office suite tools (MS Word, Excel, PPT, Visio)
• Proven planning skills; ability to create and track detailed project plans
• Detail savvy with excellent critical thinking skills
• Effective independent clinical monitoring skills

Skills For Associate Clinical Research Associate Resume

• Excellent communication skills (interpersonal, written, verbal, listening)
• + Good planning and organization skills
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project
• Excellent written and oral communication skills including presentations
• Evidence of problem-solving skills
• Organizational, prioritization and time management skills
• Plans, Manages Time and Prioritizes Effectively

Skills For Field Clinical Research Associate, Spain Resume

• Good computer skills: Word, Excel, PowerPoint, Outlook
• Good English & communication skills
• Fluent written and verbal communication skills in Swedish including a good command of English language
• Strong communication skills, ability to influence others
• Exhibit good project management skills, the ability to multi-task and manage projects independently

Skills For Clinical Research Associate, Istanbul Resume

• Strong communication skills (both written and verbal) in both local language and English
• Interpersonal skills to develop/optimize strong site relationships
• Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and
• Excellent communication, organizational skills, and attention to detail
• Excellent interpersonal skills, ability to elicit patient cooperation and work in interdisciplinary team harmoniously

Skills For Clinical Research Associate, Korea Resume

• Strong written and verbal English communication skills are essential
• Excellent written and verbal communication skills. Professional proficiency in both spoken and written English is required
• Strong written and verbal communication skills in applicable languages), and business level command of English
• Good organization skills; knowledge of GMP regulations
• Demonstrate technical expertise in computer skills and proficiency on all systems utilized by GSK throughout the lifecycle of a study
• Strong computer skills and the ability to quickly learn and utilize all systems as required by GSK throughout the lifecycle of a study
• Excellent interpersonal, judgment, and time management skills
• Demonstrated IT and administrative skills
• Excellent English & German language skills

Skills For Clinical Research Associate, Melbourne Resume

• Demonstrated skills in computers, communication, organization, and team effort
• Excellent organizationalskills. Ability to manage time and work independently
• Seeks out opportunities to demonstrate skills and knowledge base to senior
• Seeks out opportunities to demonstrate skills and knowledge base to senior leaders
• Communicate and work with international teams; good English skills, written and oral, required

Skills For Clinical Research Associate Cra-norway Resume

• Exhibits strong planning and organizational skills and high level of flexibility in a dynamic environment with
• Effective oral and written communication skills in English and Dutch
• Strong communication and presentation skills; and
• Excellent organizational skills and be able to work on projects/tasks simultaneously
• Interpersonal, leadership, organizational and effective time management skills
• Excellent communication skills and independent, multi-tasking and collaborative in a cross-functional team
• Strong knowledge of GCP's, ICH guidelines and study management skills
• Effective interpersonal and written / verbal communication skills

List of Typical Responsibilities For a Clinical Research Associate Resume

Responsibilities for senior clinical research associate resume.

• Site management and site staff performance including monitoring all types of clinical trials ensuring adherence to Good Clinical Practices, investigator integrity and compliance with all study procedures
• Good computer skills on actual programs
• Communicating and coordinating effectively with research teams and HSPB colleagues
• Clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting (including 2+ years on-site monitoring experience)
• Prepares and completes monitoring visit reports and letters and effectively documents site communications
• Demonstrated experience performing site initiation visits, site qualification
• Prior experience reviewing Informed Consent Forms in order to obtain IRB approval

Responsibilities For Lead Clinical Research Associate Resume

• Moderate experience as a CRA in directly relatable site management, or clinical site conduct experience
• Discretionary decision-making skills
• Two years of coordination of medical data experience or four years of RN experience required
• Communicate effectively, both written and orally cross-functionally - with colleagues, management and senior management
• Work effectively with patients, medical faculty and staff
• Effectively coordinates all functional areas involved in clinical trials to solve problems and assure progress and timely completion of study goals
• Clinical trial experience (CRO, healthcare settings and industry experience are acceptable)

Responsibilities For Clinical Research Associate, Dermatology Resume

• Experience in clinical research setting necessary, preferably with specific experience managing multicenter investigator-initiated trials
• Experience working in multi-site research studies requiring relationship management and prioritization
• Working knowledge of applicable clinical research principles and concepts, including Good Clinical Principles
• Monitoring experience in clinical development phase II-IV
• Understanding of FDA guidelines and regulations and principles of Good Clinical Practices (GCPs)
• Supporting site compliance with Good Clinical Practice (GCP)
• Solid understanding of clinical processes including clinical monitoring, data management, bio-statistics, medical writing, drug safety and regulatory affairs
• Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management
• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in France (1 year)

Responsibilities For Lead Clinical Research Associate Amea Resume

• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in France (approximately 4 years)
• Clinical research independent monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Committee experience (CEC/DSMB/Steering)creating/leading independent physician committees
• Applies planning techniques for monitoring visits to ensure efficient and effective monitoring
• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Ukraine
• Clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)
• Experienced with planning, directing, and coordinating projects

Responsibilities For Associate Clinical Research Associate Resume

• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Norway
• Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Finland
• Experience in organizing and maintaining electronic filing systems for rapid, easy retrieval by self and others
• Experience with the development of protocols including formatting and preparation, ICFs, and study monitoring plans
• Previous clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits) in Belgium

Responsibilities For Field Clinical Research Associate, Spain Resume

• 27) Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards
• Experience managing a core lab (Imaging, Echo or CT)
• Moderate practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO
• Practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO
• Demonstrates diligent and self-motivated approach to working in an off-site and independent working environment
• Relevant experience working in the pharmaceutical industry (including CROs, clinical sites, labs and biorepositories)
• Relevant technical experience working with biospecimen management, lab management, biobanking, or similar organizations
• Has a very good understanding and working knowledge of Clinical Study Regulatory requirements
• Experience developing Case Report Forms (CRFs), eCRFs, manual of operations and study monitoring plans

Responsibilities For Clinical Research Associate, Istanbul Resume

• Previous experience working in a healthcare setting required
• Previous nominal practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO in CNS area
• A good working knowledge of conducting clinical trials in general and specifically in oncology/ Medical Devices or Dermatology
• Experience in reporting and publishing clinical investigations within a medical environment
• Experience writing and maintaining SOPs
• Experience working in a clinical setting
• Experience with electronic or remote data capture monitoring as well as paper-based monitoring
• Collect and review of regulatory and site documents prior to study initiation and during study conduct
• 26) Demonstrates an understanding of the job description, performance expectations, and competency assessment

Responsibilities For Clinical Research Associate, Korea Resume

• Clinical research monitoring experience through a clinical research organization (CRO) or pharmaceutical company
• Practical experience with cell culture analytical equipment for all typical upstream unit operations used in biomanufacturing
• Excellent record keeping abilities to adequately record, analyze and document process development data
• Monitoring experience
• Experience running interventional clinical trials
• Demonstrated core understanding of medical terminology, medical records and clinical trial activities

Responsibilities For Clinical Research Associate, Melbourne Resume

• Previous pharmaceutical or medical device clinical study coordination, clinical site monitoring, or management experience required
• Extensive clinical monitoring experience
• Previous documented monitoring experience in clinical research
• At least 1.5 years’ monitoring experience in clinical development phase II-IV
• At least four years of on-site monitoring experience

Responsibilities For Clinical Research Associate Cra-norway Resume

• Successful completion of a CRA Trainee Program and at least one year of on-site monitoring experience
• On-site monitoring experience
• Off-site experience: familiarity with basic category of Clinical Monitoring Associate tasks
• As a clinical research associate, with diverse experience in all stages of study activity (start-up, monitoring and close-out)
• ICH-GCP experience and monitoring
• Knowledge of the dentistry sector and strong scientific understanding

Related to Clinical Research Associate Resume Samples

Clinical research manager resume sample, clinical research physician resume sample, senior / clinical research associate resume sample, engineer, research resume sample, senior clinical research resume sample, post-doctoral research resume sample, resume builder.

Entry Level CRA (Clinical Research Associate) Resume Sample

An entry-level resume for a clinical research associate or CRA position is not much different from one where experience is the main focus.

However, you do need to keep a few things in mind when writing an entry-level resume. For one, you are a newbie to the employment world. Your first impression counts immensely.

Secondly, since you do not have the benefit of experience or work-related accomplishments, it might be a bit difficult to make an impactful impression.

Nonetheless, your best efforts are required when creating a resume for an entry-level position.

You may be new to the employment world, but there must be something in your background that makes it easy for you to write a resume with pride.

The following entry-level resume sample for a CRA position provides a solid foundation for graduates looking to enter the clinical research field, showcasing educational background, relevant experience, and key competencies in a professional format suitable for a beginner’s resume.

Entry Level CRA Resume Sample 1

Jane Doe 1234 Maple Lane Seattle, WA 98101 (123) 456-7890 janedoe @ email . com

CLINICAL RESEARCH ASSOCIATE

OBJECTIVE Detail-oriented and meticulous individual, holding a Bachelor’s Degree in Life Sciences, eager to apply theoretical knowledge in a practical environment. Looking to leverage skills in trial design and data integrity at XYZ Pharmaceuticals to aid in the successful execution of clinical research and trials.

HIGHLIGHTS OF QUALIFICATIONS • Strong understanding of clinical trial protocols and compliance requirements. • Proficient in data collection, verification, and analysis ensuring high data integrity. • Excellent organizational skills with the ability to manage multiple tasks efficiently. • Strong communication skills, capable of effectively coordinating with teams and managing stakeholder relationships.

CORE COMPETENCIES • Study Protocol Adherence • Clinical Research Regulations • Data Management • Ethical Compliance • Patient Interaction • Detail-Oriented Documentation • Problem-Solving Abilities • Team Collaboration

EDUCATION Bachelor’s Degree in Life Sciences University of Washington, Seattle, WA – 2023

RELEVANT PROJECTS

Undergraduate Research Assistant University of Washington, Seattle, WA Jan 2022 – Dec 2023 • Supported the research team in the design and implementation of study protocols. • Contributed to the preparation and submission of regulatory documentation. • Assisted in the collection and analysis of research data, ensuring compliance with ethical standards. • Participated in meetings and presented findings to peers and supervising faculty.

VOLUNTEER EXPERIENCE

Volunteer Health Right Clinic, Seattle, WA June 2021 – August 2021 • Provided administrative support in patient record management. • Assisted healthcare professionals in patient care and data recording. • Played a key role in organizing health awareness camps, and enhancing community engagement.

ADDITIONAL SKILLS • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) • Basic knowledge of SAS and SPSS software • Effective communication and interpersonal skills

AWARDS & HONORS • Dean’s List for Academic Excellence, 2021-2023 • Recipient of the College Scholar Award for Outstanding Undergraduate Research

Entry Level Clinical Research Associate Resume Sample 2

Frank Lone 585 6th Street Cleveland, OH 88581 (000) 591-3729 franklone @ email . com

  CLINICAL RESEARCH ASSOCIATE

OBJECTIVE Self-motivated, and visionary individual with a deep interest in developing and writing trial protocols to outline the purpose and methodology of each trial. Eager to work for ABC Company to prepare integrated medical reports and design and set up correlating study centers.

HIGHLIGHTS OF QUALIFICATIONS • Competent in reviewing study requirements by conducting pre-study visits and drafting evaluation reports. • Highly skilled in ensuring the quality of clinical trial projects by efficiently verifying materials and data integrity. • Well-versed in assessing trial sites and personnel and ensuring consent with patient consent processes. • Adept at drafting appropriate intervention plans to avoid redundant errors and deviations.

SPECIAL KNOWLEDGE • Timelines Management • Regulatory Compliance • Practice Harmonization • Intervention Plans • Investigator Selection • Trial Monitoring • Data Verification • Technical Trial Reports • Study Documentation

EDUCATION Bachelor’s Degree in Life Sciences Cleveland Technical College, Cleveland, OH – 2024

INTERNSHIP EXPERIENCE

Intern   Blue Lab, Cleveland, OH Sep 2022 – Jan 2024 • Assisted in designing, implementing, and monitoring clinical trials • Helped in preparing integrated medical and periodic reports, in addition to reviewing and submitting case report forms • Assessed trail sites and personnel while ensuring that the quality of collected data complied with set protocols • Supported the drafting of intervention plans for the avoidance of redundancies or data errors • Documented site visits and created and issued reports and follow-up documents • Assisted in identifying potential investigators and facilitating effective communication among investigative sites and participants • Provided support in closing down study centers upon completion of study trials

AWARDS & HONORS • Awarded appreciation letter for immense contribution to the life sciences lab through voluntary summer services. • Chosen as the teacher’s assistant for 55 students, owing to exceptional participation in class and special projects.

• Clinical Research Associate Resume Example
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Clinical Research Associate CV example (CRA)

Landing a good Clinical Research Associate role can be tough in today’s competitive job market, but having a strong CV will make it much easier.

This guide will show you how to write a winning CV, and even includes a CRA CV example to help you get started.

Guide contents

• Clinical Research Associate CV example
• CV layout and format
• Your CV profile
• Work experience

Education section

CV templates 

This CV example demonstrates the type of info you should be including within your Clinical Research Associate CV, as well as how to format and structure the information in a way which looks professional and is easy for time-strapped recruiters to read.

This is the look and feel you should be aiming for, so remember to refer back to it throughout your CV writing process.

Build your CV now 

Clinical Research Associate CV layout and format

Think your CV is just about the content within it? Think again.

Your CV needs to look professional and be easy for recruiters to read, meaning the structure and format of your CV are just as important as the written content within it.

Facilitate ease of reading by using a simple structure which allows anybody to easily navigate your experience.

Formatting advice

• Length: Recruiters will be immediately put off by lengthy CVs – with hundreds of applications to read through, they simply don’t have the time! Grabbing their attention with a short, snappy and highly relevant CV is far more likely to lead to success. Aim for two sides of A4 or less.
• Readability : By clearly formatting your section headings (bold, or a different colour font, do the trick) and breaking up big chunks of text into snappy bullet points, time-strapped recruiters will be able to skim through your CV with ease.
• Design: While it’s okay to add your own spin to your CV, avoid overdoing the design. If you go for something elaborate, you might end up frustrating recruiters who, above anything, value simplicity and clarity.
• Avoid photos: Ditch logos, images or profile photos . Not only do they take up valuable space, but they may even distract recruiters from your important written content.

CV structure

For easy reading, write your CV to the following CV structure:

• Contact details – Make it easy for recruiters to get in touch with you by listing your contact details at the top of your CV.
• Profile – A short and snappy summary of your experience and skills, showcasing what makes you a good fit for the position.
• Work experience / career history – Note down all your work history, with your current position first, then working backwards.
• Education – A short list of your academic background and professional/vocational qualifications.
• Interest and hobbies – This is an optional section, which you can use to highlight any relevant hobbies or interests.

Now I’ll tell you exactly what you should include in each CV section.

CV Contact Details

Write your contact details in the top corner of your CV, so that they’re easy to find but don’t take up too much space.

You only need to list your basic details, such as:

• Mobile number
• Email address
• Location – Don’t list your full address. Your town or city, such as ‘Norwich’ or ‘Coventry’ is perfect.
• LinkedIn profile or portfolio URL – Remember to update these before listing them on an application.

Clinical Research Associate CV Profile

Grab the reader’s attention by kick-starting your CV with a powerful profile (or personal statement , if you’re a junior applicant).

This is a short introduction paragraph which summarises your skills, knowledge and experience.

It should paint you as the perfect match for the job description and entice recruiters to read through the rest of your CV.

Tips for creating an strong CV profile:

• Keep it concise: When it comes to CV profile length, less is more, as recruiters are often time-strapped. Aim for around of 3-5 persuasive lines.
• Tailor it: No matter how much time you put into your CV profile, it won’t impress if it’s irrelevant to the role you’re applying for. Before you start writing, make a list of the skills, knowledge and experience your target employer is looking for. Then, make sure to mention them in your CV profile and throughout the rest of your application.
• Don’t add an objective: If you want to discuss your career objectives, save them for your cover letter , rather than wasting valuable CV profile space.
• Avoid cliches: If there’s one thing that’ll annoy a recruiter, it’s a clichè-packed CV. Focus on showcasing your hard skills, experience and the results you’ve gained in previous roles, which will impress recruiters far more.

Example CV profile for Clinical Research Associate

What to include in your clinical research associate cv profile.

• Summary of experience: Start with a brief summary of your relevant experience so far. How many years experience do you have? What type of companies have you worked for? What industries/sectors have you worked in? What are your specialisms?
• Relevant skills: Highlight your skills which are most relevant to CRA jobs, to ensure that recruiters see your most in-demand skills as soon as they open your CV.
• Essential qualifications: Be sure to outline your relevant Clinical Research Associate qualifications, so that anyone reading the CV can instantly see you are qualified for the jobs you are applying to.

Quick tip: If spelling and grammar are not a strong point of yours, Use our quick-and-easy CV Builder to add pre-written content that has been created by recruitment experts, and proofread by our team.

Core skills section

Underneath your profile, write a core skills section to make your most relevant skills jump off the page at readers.

It should be made up of 2-3 columns of bullet points of your relevant skills.

Before you do this, look over the job description and make a list of any specific skills, specialisms or knowledge required.

Then, make sure to use your findings in your list. This will paint you as the perfect match for the role.

Work experience/Career history

By now, you’ll have hooked the reader’s attention and need to show them how you apply your skills and knowledge in the workplace, to benefit your employers.

So, starting with your most recent role and working backwards to your older roles, create a thorough summary of your career history to date.

If you’ve held several roles and are struggling for space, cut down the descriptions for your oldest jobs.

Structuring your roles

If you don’t pay attention to the structure of your career history section, it could quickly become bulky and overwhelming.

Get in recruiters’ good books by creating a pleasant reading experience, using the 3-step structure below:

Begin with a summary of your role, detailing what the purpose of your job was, who you reported to and what size of team you were part of (or led).

Key responsibilities

Next, write up a punchy list of your daily duties and responsibilities, using bullet points.

Wherever you can, point out how you put your hard skills and knowledge to use – especially skills which are applicable to your target role.

Key achievements

Round up each role by listing 1-3 key achievements , accomplishments or results.

Wherever possible, quantify them using hard facts and figures, as this really helps to prove your value.

After your work experience, your education section should provide a detailed view of your academic background.

Begin with those most relevant to CRA jobs, such as vocational training or degrees. If you have space, you can also mention your academic qualifications, such as A-Levels and GCSEs.

Focus on the qualifications that are most relevant to the jobs you are applying for.

Interests and hobbies

This section is entirely optional, so you’ll have to use your own judgement to figure out if it’s worth including.

If your hobbies and interests could make you appear more suitable for your dream job, then they are definitely worth adding.

Interests which are related to the industry, or hobbies like sports teams or volunteering, which display valuable transferable skills might be worth including.

Writing your Clinical Research Associate CV

An interview-winning CV for a Clinical Research Associate role, needs to be both visually pleasing and packed with targeted content.

Whilst it needs to detail your experience, accomplishments and relevant skills, it also needs to be as clear and easy to read as possible.

Remember to research the role and review the job ad before applying, so you’re able to match yourself up to the requirements.

If you follow these guidelines and keep motivated in your job search, you should land an interview in no time.

Best of luck with your next application!

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Clinical Research Associate resume examples for 2024

A clinical research associate resume should highlight the candidate's experience with clinical trials, patient management, and regulatory compliance. According to Dr. DeQuan Smith , Assistant Director of Graduate Education and Career Connections at Morehouse School of Medicine, "project management certifications such as the Project Management Professional (PMP) and PMI Agile Certified practitioner (PgMP) have been increasingly attractive to employers seeking candidates in the corporate sector." These skills are crucial as they demonstrate the candidate's ability to manage clinical trials effectively and efficiently. Additionally, experience with data collection, informed consent, and site management can also be beneficial.

Clinical Research Associate resume example

How to format your clinical research associate resume:.

• Use the job title 'Clinical Research Associate' in your resume to match your application.
• Focus your work experience on specific achievements that demonstrate compliance with regulations, data management, and site management.
• Limit your resume to one page, prioritizing relevant and recent experience.

Choose from 10+ customizable clinical research associate resume templates

Choose from a variety of easy-to-use clinical research associate resume templates and get expert advice from Zippia’s AI resume writer along the way. Using pre-approved templates, you can rest assured that the structure and format of your clinical research associate resume is top notch. Choose a template with the colors, fonts & text sizes that are appropriate for your industry.

Entry level clinical research associate resume example

Clinical research associate resume format and sections, 1. add contact information to your clinical research associate resume.

Clinical Research Associate Resume Contact Information Example # 1

Hank Rutherford Hill

St. Arlen, Texas | 333-111-2222 | [email protected]

2. Add relevant education to your clinical research associate resume

Your resume's education section should include:

• The name of your school
• The date you graduated ( Month, Year or Year are both appropriate)
• The name of your degree

If you graduated more than 15 years ago, you should consider dropping your graduation date to avoid age discrimination.

Optional subsections for your education section include:

• Academic awards (Dean's List, Latin honors, etc. )
• GPA (if you're a recent graduate and your GPA was 3.5+)
• Extra certifications
• Academic projects (thesis, dissertation, etc. )

Other tips to consider when writing your education section include:

• If you're a recent graduate, you might opt to place your education section above your experience section
• The more work experience you get, the shorter your education section should be
• List your education in reverse chronological order, with your most recent and high-ranking degrees first
• If you haven't graduated yet, you can include "Expected graduation date" to the entry for that school

Check More About Clinical Research Associate Education

Clinical Research Associate Resume Relevant Education Example # 1

Bachelor's Degree In Public Health 2001 - 2004

Strayer University Washington, DC

Clinical Research Associate Resume Relevant Education Example # 2

Master's Degree In Health Care Administration 2013 - 2014

Excelsior College Albany, NY

3. Next, create a clinical research associate skills section on your resume

Your resume's skills section should include the most important keywords from the job description, as long as you actually have those skills. If you haven't started your job search yet, you can look over resumes to get an idea of what skills are the most important.

Here are some tips to keep in mind when writing your resume's skills section:

• Include 6-12 skills, in bullet point form
• List mostly hard skills ; soft skills are hard to test
• Emphasize the skills that are most important for the job

Hard skills are generally more important to hiring managers because they relate to on-the-job knowledge and specific experience with a certain technology or process.

Soft skills are also valuable, as they're highly transferable and make you a great person to work alongside, but they're impossible to prove on a resume.

Example of skills to include on an clinical research associate resume

The Community Reinvestment Act - CRA is a federal law that encourages federal reserves, financial institutions - certain insured custodians, savings banks, and other lenders to meet the borrowing needs of borrowers in all segments of the community.

Oncology is defined as the facet of medicine that deals with cancer. Oncology also deals with the prevention and diagnosis of these diseases. A medical professional who has studied the discipline of oncology is referred to as an ‘oncologist'. An oncologist can further specialize in their discipline and become a medical oncologist, surgical oncologist, or radiation oncologist.

Data collection means to analyze and collect all the necessary information. It helps in carrying out research and in storing important and necessary information. The most important goal of data collection is to gather the information that is rich and accurate for statistical analysis.

An institutional review board (IRB), is a form of committee that applies research ethics by vetting research procedures to ensure they are ethical. In order to decide whether or not research can be undertaken, they often perform a kind of risk-benefit analysis. The IRB's function is to ensure that adequate safeguards are in place to protect the interests and health of humans who are participants of a research sample.

Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

The administrative process that involves collecting and keeping the data safely and cost-effectively is called data management. Data management is a growing field as companies rely on it to store their intangible assets securely to create value. Efficient data management helps a company use the data to make better business decisions.

Top Skills for a Clinical Research Associate

• Patients , 8.9%
• Informed Consent , 6.6%
• Clinical Trials , 5.5%
• Other Skills , 73.4%

4. List your clinical research associate experience

The most important part of any resume for a clinical research associate is the experience section. Recruiters and hiring managers expect to see your experience listed in reverse chronological order, meaning that you should begin with your most recent experience and then work backwards.

Don't just list your job duties below each job entry. Instead, make sure most of your bullet points discuss impressive achievements from your past positions. Whenever you can, use numbers to contextualize your accomplishments for the hiring manager reading your resume.

It's okay if you can't include exact percentages or dollar figures. There's a big difference even between saying "Managed a team of clinical research associates" and "Managed a team of 6 clinical research associates over a 9-month project. "

Most importantly, make sure that the experience you include is relevant to the job you're applying for. Use the job description to ensure that each bullet point on your resume is appropriate and helpful.

• Perform Vitals, ECG and draw Blood in the screening process.
• Ensured the success of 11 Clinical sites through data cleaning, launching of a new sub-study and site FDA audits.
• Assist researchers with IRB/routing processes, specimen collection/transfer, etc.
• Worked with PI (Principal Investigator) and Clinical Data Management team to resolve study data discrepancies.
• Collaborated with PI on clinical protocol development, design and submission to the IRB.
• Instructed patients on various surgical-related issues including pre-operative and post-operative care, surgical procedures, anesthesia, medications and wound management.
• Served as member of Leadership Group GOAL and the CSICU quality improvement committee.
• Coordinated hospital services including palliative care and hospice services.
• Monitored EKG, respiratory, and oxygen levels via telemetry and oversaw delivery of pharmacologic agents.
• Functioned as preceptor for new hire RN's.
• Monitored the assigned clinical trial following company SOPs and in accordance with GCP.
• Conducted face-to-face interviews with HIV positive study participants.
• Project Management, improved performance in drug and device clinical trials for general Urology and Urology Oncology.
• Documented data points and screened new patients using ALIAS-2 study criteria and NIH Stroke Scale.
• Monitored multiple Phase II and III trials at 14 clinics
• Aided customers with the research and purchase process of Apple products, offered product tutorials and demonstrations.
• Educated consumers on Apple brand products while creating an personalized experience with each customer to generate excitement about their potential purchase.
• Enrich people's lives through meaningful dialogue about Apple devices and products.
• Transform Apple Store visitors into loyal Apple customers.
• Approach customers promptly, in engaging ways, and follows APPLE STEPS OF SERVICE.

5. Highlight clinical research associate certifications on your resume

Specific clinical research associate certifications can be a powerful tool to show employers you've developed the appropriate skills.

If you have any of these certifications, make sure to put them on your clinical research associate resume:

• Certified Clinical Research Professional (CCRP)
• Certified Clinical Research Associate (CCRA)
• Certified Clinical Research Coordinator (CCRC)
• Clinical Trial Investigator (CTI)
• Project Management Professional (PMP)
• Professional Researcher Certification (PRC)

6. Finally, add an clinical research associate resume summary or objective statement

A resume summary statement consists of 1-3 sentences at the top of your clinical research associate resume that quickly summarizes who you are and what you have to offer. The summary statement should include your job title, years of experience (if it's 3+), and an impressive accomplishment, if you have space for it.

Remember to emphasize skills and experiences that feature in the job description.

Common clinical research associate resume skills

• Informed Consent
• Clinical Trials
• Clinical Trial Management
• Data Collection
• Data Management
• Site Management
• Site Monitoring
• Regulatory Submissions
• Consent Forms
• Clinical Sites
• Study Sites
• Clinical Practice
• Clinical Data
• Project Management
• Clinical Research Studies
• ICH Guidelines
• Site Selection
• Investigative Sites
• Study Start-Up
• Site Initiation
• Study Procedures
• Federal Regulations
• Trip Reports
• Excellent Interpersonal
• Query Resolution
• Excellent Computer
• Investigational Product
• Regulatory Compliance
• Drug Accountability
• Data Queries
• Routine Monitoring
• Field Training
• Study Initiation
• Site Compliance

Entry level clinical research associate resume templates

Clinical Research Associate Jobs

Links to help optimize your clinical research associate resume.

• How To Write A Resume
• List Of Skills For Your Resume
• How To Write A Resume Summary Statement
• Action Words For Your Resume
• How To List References On Your Resume

Updated June 25, 2024

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

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Clinical Research Resume Samples

The guide to resume tailoring.

Guide the recruiter to the conclusion that you are the best candidate for the clinical research job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

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• Prepare budgets for research protocols and obtain research grants by preparing and writing protocol applications
• Collect and maintain data for ongoing research and academic protocols in the DMH
• Medical discharge planning
• Major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy
• Provides diagnostic and therapeutic procedures (including but not limited to)
• Psychosocial history taking
• Retrieve, sort and collect data from hard copy and electronic databases. Collect and maintain data for ongoing research and academic protocols
• Provides direct personnel management and supervision, while mentoring and training new or junior research staff and providing adequate team coverage plans
• Participate in CTO Leadership Meetings and ad hoc CTO Working Groups while working closely and collaboratively with fellow CTO Program Managers and Director
• Plans and manages study site activities and provides ongoing updates of site status to management
• Oversee, develop, and manage CDM staff with the goal of maintaining quality processes and practices in the management of clinical research information
• Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
• Oversees all aspects of human resource management including recruitment and retention of assigned staff and ongoing staff performance evaluations
• Responsible for managing the development, initiation, functionality, progress and completion of clinical databases used in clinical studies managed in the DCC
• Provides leadership and oversight for activities undertaken by Clinical Operations (CO) Site Management & Monitoring personnel in charge of implementing and monitoring clinical studies conducted within country (ex-US)/ region (US) of responsibility
• In the country/region based, manages activities of clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol
• May conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCP’s), ICH Guidelines, and AbbVie Standard Operating Procedures (SOP’s) and business processes
• Conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives
• In the country/region based, manages the SCRAs responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies
• Builds and maintains a high performance team of monitoring staff
• In country based, may provide administrative management oversight to up to 8 Study Leads responsible for conduct of study at local level
• Excellent knowledge of regulations that apply to clinical studies
• Able to maintain good relationships with physician and other medical providers
• Strong negotiating skills
• Strong leadership skills essential
• Mentor team members to encourage personal and professional growth
• Ability to prioritize and manage time efficiently
• Working knowledge of SOPs/regulations relevant to clinical research
• Ability to exercise independent judgment
• Relevant therapeutic area experience desirable
• Good written and oral communication, interpersonal, analytical, conflict resolution, and problem-solving skills

15 Clinical Research resume templates

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• Able to practically apply strong knowledge of the federal regulations governing the protection of human subjects e.g. FDA, GCP/ICH guidelines, OHRP and HIPAA regulations
• Attends and actively participates in all internal and external protocol start up orientations
• Acts as the primary site contact for the sponsor’s CRA for assigned industry trials
• Able to practically apply knowledge in research regulations, including the reporting of Serious Adverse Events (SAE) and protocol violations
• Ensures that collection of clinical data is available to the PI, Sponsor and CRO in a timely manner
• For in house, NCI sponsored and Cooperative Group studies, interacts with QA Team to ensure accuracy of CRFs prior to submission
• If required by protocol, contacts patient or family for survival status after patient is taken off treatment; ensures that the Café database status fields are updated until patient death. If delegates to Data Specialist I, will orient to process and oversee
• Participates in QAMC audits by thoroughly reviewing assigned patient chart and reporting on results
• Independently prepares for and participates in NCI, FDA, pharmaceutical and other audits for assigned trials, as well as any other trials assigned to the CISO CRA’s Team
• Has necessary experience and knowledge to assist Study Coordinator with patient work ups
• Provides assistance and input to the PI for publishing study results when requested
• When requested, assists with orienting, training and mentoring newly hired Data Specialists I
• Provides assistance and guidance to Data Specialists I and II in identifying and assessing protocol violations
• Provides assistance and guidance to Data Specialists I and II in completing protocol required SAE reports
• Follows CISO SOPs in conduct of work
• Knowledgeable about and complies with hospital regulations
• Follows Medical Records rules for using and returning charts and accessing EPF and Affinity (LAC)
• Attends and participates in required internal and external meetings and conference calls with sponsors
• Ensures work environment is organized to function efficiently
• Observes office etiquette, by acting courteously and professionally with fellow staff members
• Reports off to assigned Data Specialists and Study Coordinator when away from office for reporting SAEs and other duties for coverage

Regional Clinical Research Associate Resume Examples & Samples

• 2+ years of relevant experience
• Bachelor's Degree in a related field or BSN
• Previous experience in the Pharmaceutical industry
• Basic medical and business knowledge
• Competency in Clinical Research or having demonstrated adequate level of proficiency within the CRA II competency profile
• Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations
• Degree in a Scientific or Healthcare discipline

Clinical Research Document Specialist Resume Examples & Samples

• Comfortable working in a fast-paced environment
• Knowledge of the HIPAA Privacy Rule $
• Experience negotiating ICF language with research centers and IRBs

Clinical Research Data Specialist Resume Examples & Samples

• BA/BS or similar preferred
• 1-3 years minimum experience in data collection / management
• Self-directed, resourceful, highly motivated, and energetic
• Mission driven, goal-oriented with commitment and passion to emerging field of AYA oncology
• Ability to work with and influence peers, project teams and management
• Must be able to work independently and with direction from the Director(s) and Program Managers
• Basic analytical skills with data analysis, data interpretation, problem solving and recommendations for action
• Excellent written and verbal communication as well as interpersonal skills
• Excellent judgment and ability to interpret information
• Excellent organizational skills and the ability to prioritize critical tasks
• Ability to convey information to and manage staff with different backgrounds, abilities and communication skill

Clinical Research Associate, Taiwan Resume Examples & Samples

• Location: Taiwan
• Arranges for the appropriate destruction of clinical supplies
• Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents
• Maintains complete, accurate and timely data and essential documents in systems utilized fortrial management (e.g. CTMS, eTMF/IF, Trial Master Source and Sharepoints
• Follows the corresponding Monitoring Guidelines for each assigned trial
• Reviews TCF for completeness and ensures archiving retention requirements, including storage in a secure area at all times
• Complies with relevant training requirements. Act as local expert in assigned protocols. Develop therapeutic knowledge sufficient to support roles and responsibilities
• Establishes and maintains good working relationships with internal and external stakeholders, in particular investigators, trial coordinators and other site staff
• May participate in the HA and IEC/IRB submission and notification processes as required/appropriate
• Act as an point of contact in site management practices
• May be assigned as a coach and mentor to a less experienced site manager
• May contribute to process improvement and training

Clinical Research Associate, Lead Resume Examples & Samples

• Provide leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work
• Define, assign, coordinate, oversee and assess utilization and productivity of the monitoring team
• Coordinate and supervise site monitoring assignments and activities
• Direct and prioritize team efforts and assess overall team progress against study timelines and metrics
• Develop performance standards for project team
• Identify and notify appropriate parties of emerging out of scope activities
• Evaluate impact on resource needs, study processes and related documents
• Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance
• Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance
• Coordinate the development, use and maintenance of study-specific processes, related documents, templates, monitoring and regulatory tools
• Define site selection and activation
• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives
• Serve as key site management trial-team member to internal and external partners
• Collaborate with internal and external partners to develop trial-specific tools and processes
• Provide input regarding the development of the CRF design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports
• Review and analyze site payments and associated site status against Clinical Operations budget
• Identify and oversee trial-related training and performance concerns of monitoring team; maintain awareness of level of performance and training needs; provide ongoing input for development of individual training plan
• Coordinate and oversee trial-specific training for CRAs which may include therapeutic in-service, reference materials, investigator meeting, team monitor training, on-site co-monitoring and training visits
• Assist with all aspects of performance management including compiling and providing feedback for team members' annual performance evaluations
• Supervise and manage monitoring trial-team members' adherence to DCRI and sponsor- specific administrative policies with guidance
• Review and approve trial-related expense reports, timesheets, and time-off requests
• Assist in the development, implementation and revision of processes, SOPs and standard forms
• Support the DCRI's mission, department goals and organizational activities
• Required:4-5 years related clinical research experience, including 3 years directly related CRA experience or clinical trial management experience
• Prior experience directly managing local and remote team of monitors ***
• Significant experience being a lead and mentor ***
• Experience with streamline monitoring on large trials or experience with managing monitoring across multiple projects
• ID knowledge and/or international experience a plus
• Experience working on a network of trials a plus (including Device, Drug, Data Mining, Biomarker Discovery, etc...) ***
• Strong protocol development experience including the ability to provide operational feedback ***
• Experience working with large budgets and aggressive timelines
• Excellent writing and speaking skills
• Strong multitasking skills and managing priorities across changing situations
• Ability to think "outside the box" is critical ***
• Track record of setting up efficient operations for monitoring (i.e. trip report review, trip scheduling , etc)
• Experience developing action plans, identifying, communicating and resolving issues identified during visits
• Experience resolving performance issues with staff ***
• Political "saviness" and maturity -experience working with more than 2 sponsors/multi partners
• Analytical, creative, methodical, and strong data skills
• Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
• Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
• Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research
• State of North Carolina license may be required.**

Clinical Research Operations Specialist Resume Examples & Samples

• Bachelor’s degree in Clinical Research/Public Health/ Business or related field
• 2 years’ experience in project management and clinical research projects
• Experience supervising, training, and/or mentoring new staff or students
• Strong leadership skills necessary for determining, recommending, and implementing improvements to policies/processes and best practices
• Familiarity with clinical terminologies
• Familiarity with FDA regulatory requirements

Cancer Clinical Research Business Manager Resume Examples & Samples

• Master's degree and six years relevant experience or combination of education and relevant experience
• User knowledge of Microsoft Office Suite
• Advanced understanding of financial principles
• Strong analytical skills to review and analyze complex financial information
• Demonstrated success in performing meticulous, high quality and compliant work
• Direct experience managing clinical trial budgets and financial activities of a Clinical Trials Office. Experience working in or with industry, and in cancer research is also desired

Breast Oncology Clinical Research Associate Resume Examples & Samples

• Knowledge of the principles of clinical research and federal regulations
• Familiarity with IRB guidelines and regulations
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred

Clinical Research Supervisor Resume Examples & Samples

• Excellent written and verbal communication skills; excellent interpersonal skills
• Good leadership, diplomacy, judgment, and decision-making skills
• Ability to manage multiple priorities in a fast-paced, deadline-driven environment
• Advanced education Ph.D., Masters, or related training in a related field
• Three to five years of clinical research experience; preferably managing clinical research involving academic and external/private sector stakeholders
• A demonstrated history of supervising research staff
• Experience in Expertise with Project Management software and creating Gantt charts Excellent analytical and problem-solving skills
• Working knowledge of FDA and NIH regulatory requirements
• Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals

Director of Clinical Research Operations Resume Examples & Samples

• Ten years related research experience
• Five years of supervisory experience
• Strong organizational, analytical, and problem-solving abilities
• Ability to work on matters of high sensitivity and confidentiality with both diplomacy and discretion

Clinical Research Technician Resume Examples & Samples

• Maintain inventory of supplies and equipment
• Ensure specimens are properly logged, handled and stored
• Operate standard laboratory and research study equipment
• Follow direction of research staff or others involved in the clinical research project work
• Strong communication and computer skills

Clinical Research Admin / Director Resume Examples & Samples

• Collaborate with the PPI, NCC, NDMC and performance site trial team members to ensure successful conduct of clinical trials by managing daily study activities
• Interact with clinical site personnel about matters concerning compliance and verification of the trial, FDA and CIRB regulatory requirements, contractual requirements, and shipment and receipt of investigational products
• Track progress and provide authorization to begin site enrollment based on the predefined criteria for each required component of a trial
• Maintain database/tracking tools which track site and subject enrollment as well as other elements pertinent to the trial execution
• Serve as a liaison between performance site personnel, the PPI, the NCC, and the NDMC trial management teams to enforce adherence to study protocol, the trial MOPP, and SAE reporting
• Assist in the development and maintenance of the trial MOPP
• Attend and assist in preparation of DSMB and Trial Investigator meetings
• Prepare monthly study update newsletters for participating sites
• Coordinate regular conference calls of steering, executive, and scientific advisory committees and face-to-face AHA Conference investigator meetings or other national meetings
• Interface with CIRB liaison regarding site CRIB approvals, annual renewals, and reporting of SAEs
• Interface with NDMC data manager regarding site and data quality issues
• Participate in site initiation visits and staff training as deemed necessary for the trial
• RCC responsibilities include acute care stroke call availability after normal business hours as required
• Ability to assist with the coordination of research studies in a particular discipline
• Ability to make independent contributions to projects and studies based on professional training or functional experience
• Must be able to interact with study sites in a professional manner
• Can accomplish work under general direction
• Capable of advising and explaining information to others
• Ability to manage moderately complex projects
• Ability to work with the NCC leadership to accomplish the necessary NCC tasks, in addition to short- and long-term goals
• Adherence to core values that were designed to create and maintain a positive work environment: Respect, Integrity, Teamwork and Excellence
• Graduate degree in natural sciences or an equivalent combination education/experience
• At least ten (10) years of work experience, with a Minimum of three (3) years of experience directly involved with clinical research or similar experience in medical field preferred
• Proficiency with regulatory guidelines for clinical trials preferred
• Proven organizational ability and strong attention to detail
• Demonstrates decision-making and problem-solving skills
• Excellent time-management skills, communication and interpersonal skills (written and oral), and computer skills including word processing, spreadsheet, and PowerPoint are required

Otolaryngology Clinical Research Coordinator Resume Examples & Samples

• Flexibility and ability to adapt to various situations
• Possess a level of comfort working with patients and clinicians
• Develops knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research
• Develops knowledge of University of Colorado Denver, UCH, and CHCO Policy and Procedures in relation to conducting multiple clinical research trials
• Develops a working knowledge of study regulations, budgets, and billing processes
• Knowledge of basic human anatomy, physiology, and medical terminology
• A bachelor's degree is required
• Minimum of 1 year clinical research experience
• Experience with both sponsor and PI initiated studies
• Strong regulatory knowledge
• Experience submitting to the Institutional Review Board
• Familiar with COMIRB policies
• Experience with data management, queries and reports
• Experience with statistical analysis

Clinical Research Data Coordinator Resume Examples & Samples

• Associate’s Degree in a related field or two years’ experience in a medical or clinical environment
• Knowledge of and experience with basic human anatomy, physiology, and medical terminology
• Experience using Microsoft Office products
• Research experience, oncology is a plus

Clinical Research RN Resume Examples & Samples

• Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, Infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures
• May be called upon to perform the following specific tests and procedures: (1) electrocardiogram; (2) blood pressure, pulse, height, weight, and temperature measurements; (3) phlebotomy and specimen processing and shipping; and (4) pulse oximetry
• Bachelor’s degree in Nursing
• One (1) or more years of RN experience in a research and/or oncology

Senior Associate, Clinical Research Resume Examples & Samples

• Ensures that all clinical trials are conducted in compliance with the study protocol and all contractual agreements to ensure subject safety, data quality and accurate study timelines, budgets and quality standards are met
• Collaborates in the conduct of clinical studies from protocol feasibility through study report generation and sign-off; Ensures that protocol as well as protocol amendments (if applicable) are prepared
• Coordinates the review of applicable study-specific essential documents including informed consent documents, case report forms (CRFs), subject directed recruitment materials, etc
• Writes Clinical Study Reports (CSRs), if needed; Ensures review and approval of CSRs ; Ensures that the monitoring plan is prepared, reviewed and approved
• Ensures timely review and approval of monitoring visit reports (May perform site (co)-monitoring when needed)
• Serves as the primary point of contact with Investigators and J&J Study Team
• Manages study timelines including key milestones
• Coordinates the processes of Due diligence, site contracting and purchase order preparation as well as invoice tracking
• Coordinates product and label requests for clinical studies
• Coordinates the collection of all the essential documents needed for the investigator initiation package (IIP); Approves the IIP prior to authorizing the initial product shipment
• Ensures investigational product has been approved, labelled, shipped, accepted and returned appropriately; Ensures accountability of Investigational Product at sites
• Ensures management of retain samples; Ensures set-up and maintenance of electronic trial master files including periodic reviews
• Ensures input and updating of study status into the global tracking system
• Participates in the generation of corrective and preventative action plans to address issues and deviations
• Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately
• A minimum of a Bachelors’ degree is required, preferably in science, engineering, medicine or related field
• A minimum of 4 years of experience in the conduct of clinical studies or equivalent is required
• Previous experience with clinical study management is preferred
• Experience with ICH/GCP guidelines is required
• This position may require up to 10% of domestic and international travel.Clinical Data Management

Clinical Research Financial Analyst Resume Examples & Samples

• Prepare a comprehensive quarterly clinical trial financial report and present the report to disease center leaders and administrators
• Review and develop new financial reporting metrics
• Assist in all new clinical research staffing decisions based upon financial analysis review
• Maintain a database of existing clinical trials with payment schedules, dollars received and dollars outstanding
• Prepare invoices as required by various study sponsors and manage collection of all outstanding receivables including milestone grid management
• Work with and assist Principal Investigators, administrators, and study teams with the allocation of personnel costs during the quarterly clinical trial offset process
• Work closely with Research Accounting to maintain and enhance clinical trial accounting policies and procedures
• Work with Research Accounting and study teams to review and monitor appropriate expenses against budget
• Serve as a resource to study teams, investigators, and institute departments in clinical research financial matters
• Bachelor's Degree in Business or related field
• 0-3 years direct experience or equivalent work experience. Previous clinical research experience preferred
• Excellent communication skills and organizational abilities are essential
• Knowledge of computer applications (Excel, Word, Access) is essential
• Visa sponsorship is not available for this position

Clinical Research Auditor Resume Examples & Samples

• Perform a minimum of 24 audits of DF/HCC clinical trials annually
• Schedule approximately 2 audits a month with the appropriate research study teams at DFCI, MGH, BWH, BIDMC, BCH, their Affiliates and at external sites engaged in multi-center research
• Prepare for scheduled audit by thoroughly reading and understanding selected protocol requirements, federal regulations, Good Clinical Practice guidelines and DF/HCC policies
• Conduct pharmacy and regulatory reviews for the selected protocol
• Conduct audit of selected participant’s source documentation including review of the electronic medical record, research files, labs etc
• Summarize and present audit findings to the Overall Principle Investigator (PI), Site PIs, and study staff at the end of on-site auditing activities during an exit interview
• Train investigators and study staff in documentation of clinical trial activity, protocol compliance and regulatory requirements
• Analyze audit findings to appropriately assign major or minor violations, rating the audit and drafting a Final Audit Report for review and approval by the Data & Safety Monitoring Manager
• Present audit findings to the Audit Committee for final evaluation
• Document audit findings and outcomes in appropriate repositories
• May perform special audits upon request (mock audits, Office for Humans Research Studies (OHRS) file reviews, IRB, Affiliate site audits, etc.) or may perform special projects at the request of the ODQ Director or Data & Safety Monitoring Manager
• Compose “Audit Alerts” to disseminate trends in audit findings across DF/HCC institutions via the research listserv (CRA II)
• Participate in training sessions regarding the DF/HCC Audit Program (preparing and/or presenting) (CRA II)
• Provide support for the maintenance of the DF/HCC Clinical Trial Audit Manual, DF/HCC Standard Operating Procedures (SOPs) pertinent to clinical trial auditing and the audit database (CRA III)
• Coordinate logistics and troubleshoot problems, such as space and access to electronic records, that may be encountered by the clinical research auditors across the DF/HCC institutions (CRA III)
• Identify needed DF/HCC system changes within DF/HCC through the extrapolation of the audit findings (CRA III)
• Provide guidance and mentoring to junior staff through co-auditing during initial training of new hires and act as a subject area expert to junior peers (CRA III)
• Bachelor’s degree in a scientific field is required at all CRA levels
• 1-2 years clinical research auditing or monitoring experience, oncology research preferred (CRA II)
• 3-5 years clinical research auditing or monitoring experience, oncology research preferred (CRA III)
• Certified Clinical Research Profession (CCRP) from an approved accrediting organization (CRA III)

Ubc-lead Clinical Research Associate Resume Examples & Samples

• Thorough knowledge of sponsor specific project requirements, protocol and timelines
• Reviews and approves Site Visit Reports and Letters within UBC and/or Sponsor timelines
• Maintains at least one active site per study assignment
• Assists with project specific training
• Ensures appropriate CRA visit scheduling per protocol; tracks, reports and escalates (as needed) adherence to site visit schedule, trip report metrics and CTMS entry of completed tasks
• Maintains Q&A log for site and monitoring issues
• Maintains and tracks Issues & Actions Log to assure timely resolution per UBC and/or Sponsor timelines
• Serves as primary liaison for clinical monitoring issues, escalating as appropriate to Project Manager and/or Functional Manager
• Attends client and project team meetings – assists with preparation, content and leading of meetings as required
• Assists with reporting on monitoring activity to include status report, co-monitoring and trip report metrics
• Acts as back-up for Project Manager and may be primary contact for UBC/Sponsor interaction
• Coordinates EDC data entry, if applicable, and DCF resolution
• Coordinates site assignments in conjunction with Project Manager and Functional Manager; assists with other project specific tasks as delegated by Project Manager
• Consistently completes on site monitoring in accordance with project specific timelines
• Attends project team meetings, departmental meetings and 1:1 with manager a minimum of monthly; responsible for content discussed during these meetings
• Consistently completes site monitoring reports, confirmation/follow-up letters per UBC and/or client SOPs; signs, scans and/or provides to CSS/RDS for filing in Trial Master File with minimal corrections required
• Enters site visits, confirmation/follow-up letters and site monitoring reports into CTMS
• Consistently completes Call Log or Telephone Contact Report detailing communication with sites in a timely manner
• Maintains regular contact with assigned sites per protocol
• Consistently completes expense reports within UBC timelines and guidelines
• Assists PM and management team by being an AIM leader
• A = Assess visit type, assess protocol specific and UBC SOP knowledge and assess individual’s ability to perform visit type independently
• I = Instruct how to conduct visit, report/letter writing and manage issues and actions
• M = Mentor team member by sharing tips/tricks/tools reviewing process prior to and after visit
• Creates and maintains clinical project documents with Project Manager oversight and finalizes with appropriate team review (PM, Sponsor, etc.)
• Includes: Clinical Management Plan, Trip Report and Letter Templates, CRF Transmittal Form, Monitoring Worksheet, input for Monitoring Plan
• Bachelor’s degree – Life Science preferred or equivalent industry and monitoring. Must have Complex Cardiovascular experience
• Displays leadership, organizational and interpersonal skills
• Proven skills with CTMS, EDC, Outlook, Excel and other basic computer software and client specific systems (if applicable)
• Up to 50% travel

Clinical Research Associate Administrator Resume Examples & Samples

• Manage data according to prescribed standards and transcribe data in case report or data forms
• Prepare documents for statistical analysis and descriptive data
• Follow-up with study subjects in accordance with research protocol(s)
• Ensure compliance with subject consenting and reporting of adverse events and side effects
• Adhere to legal, professional, and ethical codes of conduct with respect to confidentiality and privacy
• Ensure that all research efforts are in compliance with Federal, agency, and IRB-specific requirements and regulations
• Schedule and maintain calendar of data collections, appointments, and updates

Clinical Research Associate Positions Resume Examples & Samples

• A minimum of two years’ experience coordinating research protocols (four years preferred) as a certified research coordinator
• A minimum of two years’ experience coordinating animal research protocols OR certification as a Research Animal Coordinator (RAC). RAC certification will be given preference
• Understanding of AAALAC and USDA regulations regarding animal subjects research
• A minimum of two years’ experience coordinating research protocols
• Clinical competence in application of professional nursing theory, practice, and skills for the care of patients

Clinical Research & Data Quality Coordinator Resume Examples & Samples

• Design and develop complex models used for health care data analysis and data mining and for complex health care data relationships to improve data collection activities, data analysis, monitor contractor performance, and member health care outcomes as they relate to Quality Improvement
• Support the E.H.R. Incentive Program with complex data analyses, including risk assessment and random audit selections, data analysis for federal report purposes and validation of provider and program data
• Assist internal and external customers with data analysis and data relationships
• Communicate among AHCCCS divisions and health plan administration for the purpose of identifying, resolving and monitoring data anomalies and general data relationship issues
• Attend internal and external meetings to answer questions, provide recommendations and participate in problem solving and decision making related to encounter data submissions, processing, analysis and health outcomes
• Interpret various administrative rules, policies and procedures pertaining to encounter and CQM data
• Significant experience in PC programming and common software tool usage including but not limited to SPSS, Microsoft Access and Excel, within the context of health care industry
• Demonstrated experience in statistical or analytical theories and techniques and data-mining skills; superior mathematical skills
• Proficient understanding of methodology requirements including but limited to HEDIS and CMS Core Measurement sets, as well as extensive understanding of data validation methods
• Strong ability to effectively lead and/or facilitate a team of professionals from within and/or outside the agency
• Demonstrated knowledge of State and Federal Policies and Procedures governing Title XIX, Title XXI, Managed Care, Long Term Care, Individuals with Special Health Care Needs, Behavioral Health and Tribal health care entities
• Advanced degree in biostatistics, statistics, epidemiology, business, health administration or related field

Clinical Research Associate, West Coast Resume Examples & Samples

• Moderate clinical research and independent field monitoring experience
• Thorough understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines and an intermediate understanding and application of applicable therapeutic standards
• Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail
• Effective command of written and spoken local language, if not English, as well as English
• Must have valid, current driver's license and ability to secure corporate credit card
• ACRP CCRA or equivalent certification/credentials strongly preferred

Senior Specialist, Clinical Research Resume Examples & Samples

• Able to function as a subject matter expert (SME) on medical device products
• Assist in the preparation of study start up activities with a high degree of skill and knowledge. Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled
• Assist in the preparation of and critically review relevant portions of regulatory submissions for local and government regulatory bodies
• Participate as a key member to provide analysis in internal protocol compliance meetings, and independent safety review meetings (e.g., DSMB, Medical Monitor, and Clinical Events Committee and protocol deviation meetings)
• Collaborate with other Clinical Research Associates and project teams to ensure that trials are conducted and maintained in a standardized way
• Extensive site management experience
• Ability to communicate and relate well with key opinion leaders and clinical personnel
• Effective written, verbal and presentation skills
• Able to build constructive and effective relationships using diplomacy and tact
• Able to identify problems and root causes while proposing potential solutions
• Strongly motivated, is able to achieve work goals, and executes through appropriate channels

Clinical Research Monitor Report Reviewer Resume Examples & Samples

• Bachelor’s Degree with 2+ years clinical research experience required
• Advanced Degree with 0+ years clinical research experience required
• Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel) required
• Previous experience in clinical monitoring preferred
• Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, etc.) preferred

Clinical Research Monitor Resume Examples & Samples

• Bachelor’s Degree in life sciences, health related disciplines or nursing
• 2-3 years Clinical Research experience (preferably with Clinical Monitoring experience)
• Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Greece
• Experience with Ethic Submissions & coordination
• Flexibility in terms of (inter)national travel (up to 80%)
• Possess a working knowledge of disease state and investigational product

Prin Clinical Research Program Resume Examples & Samples

• Bachelor’s degree and 7+ years of project management experience OR
• Master's degree and 5+ years of project management experience OR
• Doctorate and 3+ years of project management experience OR
• M.D., *D.V.M. (*Board Certified)
• Expert in MS Project (or similar scheduling software) and Excel skills
• Medical device or regulated industry experience
• PMP certification
• Perform work without appreciable direction. Exercises considerable latitude in determining objectives and approaches to

Cra-senior Site Clinical Research Associate Resume Examples & Samples

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol in an off-site and affiliate based capacity
• Conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes
• May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues)
• May train and provide guidance to junior staff. Responsible for compliance with applicable Corporate and Divisional Policies and procedures
• Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
• Reports and escalates serious or outstanding issues to project team member(s) and/or ACOM/ COM/ Sr. COM as appropriate, as defined in the study monitoring plan
• Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline by enhancing the enrollment schedule of clinical investigative sites
• May act as back-up or secondary reviewer for other countries as required
• Participates in field training and mentoring of new/junior SCRAs as well as insourced SCRAs
• Manage and liaise with appropriate functions to respond to CA and/or EC questions and related follow-up
• Employs good financial management to conserve costs of departmental operation and controls travel expenses, with guidance from Senior ACOM/ COM/ Sr. COM as appropriate
• Identifies, evaluates and recommends new/potential investigators/sites on an on-going basis.( Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.)
• Participates in special projects/work groups

Senior Site Clinical Research Associate Resume Examples & Samples

• Provides input to forcast resource requirements for assigned clinical studies in the country(ies) responsible for
• Advises on pre-audit activities for btoh PV and GCP requirements
• Ensures audit and inspection readiness in clinical sites within country(ies)/region(s) of responsibility
• Ensures study-related parameters are tracked as appropriate
• In country based, might administer budget for salary and operating expenses and might review and approve expenditures to achieve cost effective operations
• Candidate should be located in Phoenix, AZ
• Minimum of 6 years clinical research experience, at least 3 years of experience in clinical site monitoring
• Experience monitoring Immunology

Site Clinical Research Associate Resume Examples & Samples

• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity
• The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites
• Bachelor’s Degree required; medical/science/nursing background is preferred
• Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to: Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs. Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
• Facilitates Quality Assurance Audit processes as indicated
• Reviews monitoring visit reports for assigned CRA’s
• Reports monitoring activities and study site conduct accurately and completely
• May provide input relative to performance review and development opportunities
• Prepares CA and/or EC documentation, ensures submissions and/or notifications are performed as applicable
• May coordinate local SCRA team working on the same projects, when applicable
• Manages investigator payments as per executed contract obligations
• Negotiates investigator/ hospital agreements with stakeholders
• Participates in and/or presents at departmental and other functional meetings as needed, including Site Management & Monitoring meetings
• Maintains appropriate communication with relevant functional areas

Clinical Research Medical Director Neuroscience Resume Examples & Samples

• Three (3) or more years of clinical research experience
• Strong background in neurodegeneration/neurobehavior
• Experience on partnered programs
• Experience and knowledge in designing, conducting and analyzing Phase 2 and/or 3 clinical trials in AD
• Familiarity with FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements, particularly for AD
• Demonstrated ability as a medical expert in a complex matrix environment

Head Clinical Research IT Resume Examples & Samples

• Ability to build strong strategic relationships with key scientific leaders of clinical research
• Demonstrated ability to get things done in a highly matrixed IT organization
• Domain expertise in clinical research, including a working knowledge of the scientific disciplines of clinical science, clinical biomarkers, pharmacology, biostatistics and bioinformatics, and how they combine to drive clinical research
• PhD/ MS in Life Sciences or a related discipline preferred
• Strong domain expertise in the application of IT to Clinical Research is essential, including a deep understanding of clinical development scientific processes and how they are supported by IT tools and systems
• 10+ years experience in leadership roles in pharmaceutical R&D IT, and/or clinical development and/or Bioinformatics
• Ability to lead the analysis of complex and ambiguous business needs, and integrate those into compelling and actionable strategic plans
• Demonstrated track record of delivering high-value capability projects in an R&D environment
• Seasoned line management skills, with a particular emphasis on energizing and developing the existing team of effective and experienced technical specialists
• Ability to create and support a dynamic culture of innovation and continuous improvement in line reports and in the matrix
• Excellent collaboration and communication skills, with the versatility to build strong partnerships with technical leaders and also become trusted advisers to senior executives
• This individual will be recognized across BMS R&D as the key leader for Clinical Research IT, and recognized internally and externally as a thought-leader in this field

Clinical Research Associate, Anemia Resume Examples & Samples

• Assist with clinical data review
• Interact with CRO and monitor trip report review
• Assists in tracking and updating study timelines

Director of Clinical Research Resume Examples & Samples

• The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide
• The successful candidate will have oversight for ongoing and planned product trials within the oncology therapeutic area
• The Clinical Research MD will report to a more senior member of the oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
• Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials
• Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans
• Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance
• Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice
• Coordinates the collection and analysis of clinical data for internal analysis and review
• Develops manuscripts for publication in peer-reviewed journals
• Will be part of a team responsible for defending the clinical development program before regulatory authorities
• Serves as a scientific and clinical resource within Gilead Clinical Research

Clinical Research Associate, Novosibirsk Resume Examples & Samples

• You hold a Medical Academy degree, nature science or any relevant education
• 2 years of experience as a CRA in international pharmaceutical company or Clinical Research Organisation
• You have the ability to analyze data; good presentation, communication skills
• You are mobile, flexible and result-oriented with a ‘can-do’ attitude
• Good command of Russian and English oral and written would be a great advantage

Clinical Research Psychologist Resume Examples & Samples

• Execute all appropriate Investigator responsibilities on assigned projects
• Serve as a Primary and Sub-Investigator on research protocols
• Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure efficient and compliant clinical operation
• Assist with the psychological and clinical oversight of all aspects of function and work performed
• Assist with training and input on performance assessments for clinical operations personnel
• Work directly with clinical operations personnel in diagnostic assessment of trial subjects, psychiatric histories, and evaluation of inclusion/exclusion criteria for study participants
• Participate in on-call and general psychiatric coverage schedules
• Liaise with sponsors on study conduct and study progression as requested
• Provide psychological consultation as required or requested by the client/sponsor or the clinical staff
• Participate in the review and coding of adverse events and concomitant medications for accuracy and consistency
• Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, and other documents as requested
• Establish working relationships with client representatives, promoting confidence and reliability regarding the clinical operations
• Represent California Clinical Trials Medical to clients in a positive and professional manner
• Provide support for marketing activities as requested
• Liaise with physician staff of Glendale Adventist, Brotman MC and local/regional medical consultants as necessary
• Participate in the review of source data and/or data listings of safety data, including adverse experiences, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and if noted, follow up as appropriate with the clinical team, project team sponsor, investigator and regulatory agencies
• Participate in the review of individual adverse experience reports for accuracy and clinical importance, and characterize their relationship to the study drug, severity and seriousness
• Provide reports to FDA or other regulatory agencies and the sponsor on a periodic and regular basis summarizing adverse experiences as required by the FDA or the sponsor as needed
• Ensure that all established timelines relating to areas of responsibility and assigned projects are met
• Ensure that the quality standard of clinical work product is met
• Perform other duties as assigned by immediate supervisor
• Detailed oriented with the ability to work in a fast paced environment
• Clinical practice experience of at least two years is preferred
• Clinical or pharmaceutical research experience desirable
• Ability to obtain and maintain an unrestricted license to practice psychological services in the state of California
• Knowledge of the FDA regulated drug development process is helpful

Field Clinical Research Associate Resume Examples & Samples

• Act as the liaison between the in house Seattle Genetics team, the CRO, vendors, and multiple clinical sites. Maintain close contact with sites by telephone, correspondence, and on-site visits
• Apply the applicable SOPs, Clinical Monitoring Plan, Research Specimen Manual and CRF Completion Guidelines as indicated
• Identify and qualify potential investigators. Perform Pre-Study Site Visits. Assist with and track start up activities including essential document review and collection, and facilitating Ethics Committee, other committee, and budget/contract review and approval process
• Perform Site Initiation Visits. Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures and CFR, and GCP/ICH Guidelines
• Perform Interim Monitoring Visits
• Perform drug accountability and ensure adequate drug supply
• Review and authorize research specimen sample shipments to central lab, as applicable
• Collaborate with Drug Safety Group to ensure that study staff complies with the serious adverse event reporting requirements
• Coordinate supply of clinical supplies to the site
• Ensure site regulatory file is complete and accurate
• Track and report progress of study, including patient enrollment/screening, data monitoring, protocol variations, issue resolution, and follow up compliance
• Prepare and submit visit trip reports, GCP Checklists and follow up letters within timelines outlined in the Clinical Monitoring Plan
• Ensure clinical trial site training records are current and maintained as required
• May assist in the preparation and follow-up of on-site Seattle Genetics sponsored quality audits, as well as, regulatory authority inspections
• Assist Data Management as required
• Complete routine administrative tasks in a timely manner
• Attend staff meetings and trainings as required
• Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable
• BA/BS or equivalent or any relevant and qualifying training with a minimum of 3 years of relevant clinical monitoring experience
• Excellent organizational, interpersonal, verbal, and written communication skills, (including experience in making presentations),
• Demonstrate ability to discuss scientific, medical and therapeutic area information
• Strong working knowledge of CFR and GCP/ICH requirements
• Flexibility towards work assignments, new learning and travel. Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail
• IT literate with a strong working knowledge of PC functions and recent experience with Microsoft based applications, Electronic Data Capture Systems, and CTMS, Impact or like system. Experience in oncology preferred, and monitoring complicated trials

Lead Clinical Research Associate Temp Resume Examples & Samples

• Essential Duties and Responsibilitiesinclude the following. Other duties may be assigned
• Responsible for the oversight and management of the assigned CRA team
• Act as a mentor to CRAs and provides on-site training as necessary
• As defined by the study project needs, recruits, qualifies, initiates, monitors, and manages clinical trial centers through all phases of clinical development (Phase I – IV)
• Serves as liaison between project management team, field sites, investigators, study coordinators, pharmacists, and staff members
• Develop and participate in CRA project-specific training
• Contributes to the preparation of IND and other regulatory documents and submissions
• Conducts trip report review for assigned projects as well as tracks visit/trip report metrics and summarize/report to teams
• Tracks utilization of visits against the budget in conjunction with the study Project Manager
• Manages data collection process and responds to questions received from clinical site regarding the protocol and any other study related issues
• As defined by the study project needs, monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation. Ensures resolution of data queries
• Assists with the development and negotiation of study budgets for clinical trial centers
• Assists in the development of clinical protocols, amendments, informed consents, CRF/ source document design, monitoring plan, site instruction manuals, protocol specific training documentation, administrative letters, and other project related documents
• Assists with the overall management of the project Trial Master File
• Tracks study enrollment, data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites
• Assists in providing data to prepare sections of the annual and final clinical study reports and clinical sections of regulatory filings
• A Bachelor’s degree in clinical development, life science or a related field is required
• Approximately 5-7 years of combined Lead CRA and site monitoring experience in the pharmaceutical or biotech industry required
• Knowledge of regulatory guidelines including GCP, ICH, CFR etc
• Excellent prior experience in all aspects of the clinical trial process
• Must be Proficient in MS Office
• Prior experience with MS Project desired
• Experience in CTMS
• Excellent organizational and communication skills are required
• Must have the ability to prioritize multiple tasks and complete projects within established deadlines

Senior Representative, Clinical Research Resume Examples & Samples

• Assess informed consent form (ICF) and collaborate with site (e.g., study coordinator) to ensure ICF includes all Code of Federal Regulations (CFR) and Edwards requirements
• Assist with query management and resolution as needed
• Maintain effective relationships with external advisors, clinical investigators, vendors, and applicable research staff
• Participate in work streams and or process improvement initiatives (e.g., RACI)
• Bachelor’s degree in a related field is preferred
• Minimum of 1 year of previous work experience working with regulatory documentation for clinical studies is required
• Proven expertise in MS Office, Adobe, and ability to operate general office machinery
• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master file) preferred
• Excellent written and verbal communication skills and interpersonal relationship skills
• Strong problem-solving and critical thinking skills
• Knowledge and understanding of international and domestic medical device regulatory guidelines relevant to clinical protocols
• Ability to manage confidential information with discretion
• Ability to interact professionally with all levels of the organization
• Must be able to work in a team environment

Manager, Clinical Research Resume Examples & Samples

• 1) Collaborate with Global Study Teams and CRO partners to ensure timely, accurate feedback throughout the conduct of the trial
• Primary point of contact to support planning and execution of Celgene-sponsored clinical trials (phase’s I-IV)
• Responsible for project leadership and site relationship management of pre-defined Clinical Trial Partner sites to support optimization of key processes and to ensure critical trial milestones/timelines are being met
• Have a comprehensive overview of all Celgene sponsored clinical study activities in Canada
• Support the Feasibility process of clinical programs and studies in collaboration with Global Clinical Research Development Operations and CRO partners, as appropriate
• Scientific/healthcare related degree
• Financial and business awareness

Clinical Research Admin Resume Examples & Samples

• Ensuring successful startup of the study at all clinical sites under the leadership of the principal investigator
• Managing, coordinating, planning and evaluating research projects or a multi-site research program for the University of Cincinnati, College of Medicine, Department of Psychiatry and Behavioral Neurosciences
• Managing and mentoring Clinical Research staff positions
• Ability to serve as a PI on own research project
• 10 years of relevant experience
• Graduate degree in health related field or equivalent experience

Oncology Clinical Research Associate Resume Examples & Samples

• Perform all clinical monitoring/site management activities for assigned projects in accordance with PAREXEL's standard operating procedures
• Educated to degree level (biological science, pharmacy or other health related discipline)
• Strong working knowledge of EDC systems, IVRS and CTMS

Lead Marketing Coordinator Clinical Research Resume Examples & Samples

• Develop long-term marketing and recruitment strategies to meet ambitious enrollment goals; strategies should include mass marketing, community outreach and engagement, and social media
• Establish connections both within and outside the University to build collaborative recruitment relationships
• Manage vendor connections and financial planning for strategies
• Manage a team of community engagement specialists/recruiters to ensure the successful enrollment in the project
• Hiring and supervising staff, conducting performance reviews, and ensuring staff are appropriately trained
• Assigns studies and tasks to staff. Ensure staff workloads are appropriate and being performed accurately
• Manage personnel and performance problems appropriately and swiftly
• Clinical Research recruitment experience, and/or experience working in an academic medical center or large health system strongly
• Experience with marketing, advertising, and/or recruitment for clinical trials
• One year of prior experience supervising, or as a manager of direct reports responsible for hiring decisions and performance reviews
• Experience in a leadership role, as well as experience mentoring and training junior staff
• Excellent public relations skills
• Ability to navigate complex systems and organizational structures
• Demonstrated understanding of program recruitment and/or ability to be resourceful and tactical in solving recruitment challenges
• The ability to work effectively with a wide range of individuals and groups at all levels of authority
• A proven capacity to set priorities, coordinate multiple assignments, work in a fast paced, multi-tasked environment, exercising sound judgment in setting priorities with a strong attention to detail is also required
• Knowledge of IRB requirements for recruitment desirable
• Demonstrated excellent organizational skills
• Ability to direct the work of others, for jobs requiring supervision

Clinical Research Associate HVT Germany Resume Examples & Samples

• Medical field degree in nursing
• Good English and German (written & spoken)
• Computer skills – Microsoft Office (Word, Excel, Access, Powerpoint), Internet
• Familiarity with hospital environment
• Good communication and organizational skills
• Detail and results oriented working style
• Experience with clinical studies in European Union (medical device trials preferred )
• Detailed knowledge of European and international regulations of Good Clinical Practice (GCP), Experience with Class II & III medical devices preferred, experience with cardiovascular clinical studies preferred, documented basic education/training in clinical research

Experienced Clinical Research Associate Resume Examples & Samples

• Previous experience as a clinical research monitor that provides the knowledge, skills, and abilities to perform the job (comparable to one year) or completion of PPD Drug Development Fellowship
• Customer focus
• Good English language and grammar skills required; French language skills would be a plus
• 1+ years experience as a field clinical research monitor (CRA) that provides the knowledge, skills, and abilities to perform the job (or completion of PPD Drug Development Fellowship)
• Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment
• Frequently drives to site locations. Frequently travels (60-80% of time) domestically with extended overnight stays
• Exposure to biological fluids with potential exposure to infectious organisms
• Personal protective equipment required such as protective eyewear, garments and gloves
• Exposure to fluctuating and/or extreme temperatures on rare occasions
• Ability to work in an upright and /or stationary position for 6-8 hours per day
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
• Frequent mobility required
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf
• Ability to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
• Frequently interacts with others to obtain or relate information to diverse groups
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task
• Regular and consistent attendance

Clinical Research Associates Resume Examples & Samples

• Excellent understanding and demonstrated application of GCPs and applicable SOPs
• Development and preparation of the local informed consent form
• Management of the delivery of study supplies
• Strong customer focus
• Effective interpersonal skills

Clinical Research Associate, Belgrade Resume Examples & Samples

• Previous experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities
• Effective organizational and time management skills
• Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software

Trainee Clinical Research Associates Resume Examples & Samples

• University degree in a science related field or are a certified health professionalMinimal clinical monitoring experience that provides the knowledge, skills, and abilities to perform the job OR equivalent combination of education, training, & experience
• Knowledge of ICH-GCP, EU and FDA requirements
• Excellent English and German skills
• Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice
• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas
• May provide assistance to less experienced clinical staff
• Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Good therapeutic and protocol knowledge as provided in company training
• Good organizational and problem-solving skills
• Effective time management skills

Clinical Research Associate, Romania Resume Examples & Samples

• University degree in a science related field
• At least 1 year independent monitoring experience in clinical development phase II-IV
• Fluency in English and in Romanian
• Good organizational and time management skills

Senior Manager, Clinical Research Projects Resume Examples & Samples

• Direct the creation and execution of clinical trial activities in accordance with Alexion SOPs, ICH Guidelines, and Good Clinical Practice (GCP)
• Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection
• Lead cross functional clinical study team to achieve study milestones
• Interact with internal and external groups to achieve study milestones
• Determine study requirements, define specifications, and initiate and lead the selection of third party
• Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and
• Manage clinical study budgets within agreed variance
• Communicate clinical studies performance data to other members of the management and medical affairs team
• Prepare and maintain and/or oversee the preparation and maintenance of required study and regulatory documentation, including but not limited to: study status reports, reports for Competent Authority submissions, informed consent form (ICF), Monitoring Plan, Pharmacy Manual, investigator contracts and budgets
• Key contributor to the development and/or review and approval of study documents including, but not limited to: protocol, case report forms (CRFs), study procedural documents, ICF, statistical analysis plan, and clinical study
• May provide input into the clinical development strategy for assigned study including but not limited to operational feasibility, budget and timeline estimates
• May participate in and/or lead department initiatives
• Conduct lessons learned exercise to help document continuous improvement process and sharing of best practices
• Develop standard operating procedure (SOPs), as required
• A solid clinical operations professional with at least 5 years’ experience in clinical research
• Must have proven technical leadership skills
• Individual must have cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes the oversight of internal and/or external stakeholders involved in the following activities: site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, legal review and regulatory affairs
• Effective verbal and written communication and presentation skills are required in relating to relevant stakeholders both inside and outside the organization
• Knowledge of team development principles and successful implementation of the same is desirable
• Track record of effective management and oversight of CROs plus ensuring ICH/GCP compliance and risk management of clinical studies is expected
• Excellent interpersonal and influencing skills
• Ability to effectively lead a cross-functional team in a matrix environment
• Experiencing writing protocols, CRFs and other study-related
• Proven problem solving and timely decision making skills
• Excellent leadership, risk management, planning and project management skills
• Ability to effectively interact with all levels of professionals and support staff
• Participate in continuous improvement initiatives in the department
• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines essential

PRN Clinical Research Technician Resume Examples & Samples

• Collect, record, and maintain volunteer screening, check-in and study data according to study-specific protocol and SOPs, ensuring quality control for content, accuracy and completeness. Record, report and interpret findings appropriately to develop study-specific database
• Prepare for clinical trials by organizing and labeling specimen collection tubes and containers, setting up equipment and documents and planning logistical activity for procedures as per study protocol
• Perform a variety of medical procedures such as venipuncture, collection of vital signs, height and weight measurements, EKGs and stool and urine collections on study volunteers according to study-specific protocols
• Monitor volunteer safety and report adverse reactions to appropriate medical personnel
• Maintain and restock medical supplies as needed. Upon conclusion of study, clean clinical areas and equipment; store equipment as necessary
• Recruit and screen volunteers for clinical trials and maintain volunteer database
• Bachelor's Degree in Life Sciences preferred
• Good skill in using MS Windows and Office applications such as Access, Power Point, Outlook and Word
• Ability to pay close attention to detail

Rn-research Clinical Research Department Days CHI Health St Francis Resume Examples & Samples

• Interpersonal skills necessary to gather and exchange information with physicians, patients, families, visitors and other hospital personnel
• Analytical skills necessary to develop and implement the coordination, collection, evaluation, and processing of clinical trial data, interpret medical documentation and lab results,
• Ability to concentrate and pay attention to detail for up to 80% of work time when charting lab work, taking physician orders, scheduling patients and so forth

RN Clinical Research Resume Examples & Samples

• Primary responsibility for this candidate is to manage research protocols by identifying study related elements, evaluating patient eligibility, development of study tools, data collection, data entry and reporting on study participants within study timelines
• Ability to manage multiple projects and report data on a regular basis while maintaining credibility and confidentiality of all patients. Keeps Physicians, Research Director informed concurrently of study enrollment, adverse events, protocol deviations, protocol violations, study progress, patient visit issues, monitoring visits, updated study requirements
• Develops and composes professional correspondence to the Institutional Review Board by accurately developing protocol specific informed consents, protocol applications and serious adverse event reporting through the Principal Investigator
• Ability to resolve queries through accurate supportive documentation. Coordinates and directs both internal and external monitoring visits and audits
• Responsible for completing Case Report Forms and databases and IRB updates in a timely manner, as well as, resolve all queries generated by the Registry
• Ability to coordinate protocols and patient visits with all sponsors and provide each sponsor with its protocol data. Obtains necessary follow in adherence with protocols

Coord Clinical Research Resume Examples & Samples

• Apprises principal investigator, Research Operations Director and Regional Site Manager of all study specific medical issues for guidance
• Assists sponsor and US FDA audit teams
• Reviews and responds to any monitoring and auditing findings and escalates issues defined by Regional Site Manager
• Maintains patient confidentiality according to ethical and legal requirements
• Assists in providing coverage for satellite clinic sites as necessary
• Responsible for coverage after hours and on weekends as necessary
• Medical and research terminology
• Knowledge of federal regulations, good clinical practices (GCP)
• Computer skills including use of clinical trial database, electronic data capture, and MS Word or
• Communicate and work effectively with a diverse team of professionals
• Organizational and prioritizing capabilities
• Work independently in a fast pace environment with minimal supervision at off-site facilities
• Clinical experience- 1+ yrs
• Clinical research experience- 3 years
• Interviews prospective subjects and assure qualifications for participation in clinical trials and obtains informed consent
• Participates in all assigned study related visits/meetings(investigator meetings may require travel) and implements the assigned clinical trials according to mutually agreed upon timelines by PI and Sponsor
• Educates subjects for elective participation in our clinical trials
• Educates clinic/hospital personnel on assigned clinical trials in protocol conduct, data collection process and related issues as applicable
• Ensures all study related personnel have completed required training and training is documented, before conducting any protocol related activities
• Actively recruits and exceeds enrollment goals in assigned clinical trials and provides monthly, written documentation of screening/enrollment/follow-up activities
• Coordinates the collection of data according to the research protocol, operation manual and case report form guidelines within the budgetary guidelines established by the Director
• Draws, prepares and ships laboratory samples for clinical trials
• Maintains investigational drug/device dispensing accountability and shipping logs according to protocol guidelines
• Instructs Principal Investigator on procedures and tests that need to be performed in compliance with the study protocol and advises PI on the results of procedures and testing; calling to attention findings of clinical importance in a timely manner
• Documents phone conversations with sponsors, study subjects, physicians, coordinating organizations, and any other pertinent resources and place in appropriate source
• Schedules follow-up visits/procedures for study subjects and provides source documentation for activities conducted during these visits
• Completes accurate and complete data entry into case report forms or pre-established computer programmed formats in a timely manner
• Coordinates, schedules and is made available for assigned study monitor visits, quality assurance audits, and query resolution of collected data in a timely manner
• Identifies strategies for patient enrollment in research studies in collaboration with the PI
• Report all serious or unexpected adverse events immediately to PI and Research Director
• Assists in maintenance of research related logs and contact data base
• Maintains up to date research knowledge through continuing education
• Actively promotes an open line of communication and a professional relationship with all members of the organization
• Utilizes appropriate resources to resolve problems. Report any unresolved issues to Director
• Possess the ability to prioritize and organize high volume workload and flexible with changing priorities to fit the daily needs of the department, patients and customers we serve
• Knowledgeable of, and adheres to all local, state, and federal research regulations and guidelines
• Performs any other duties as assigned

Clinical Research Associate, Work From Home Resume Examples & Samples

• Detail-oriented with knowledge of scientific, medical, and regulatory terms
• Knowledge of ICH Guidelines, GCP, and FDA regulations
• Understanding of the drug/device development process
• Computer skills, including MS Word, Excel, Outlook, and PowerPoint; ability to learn new
• Professional writing and communication skills
• Ability to multi-task in fast paced environment is essential
• Ability to function in a team environment under time and resource pressures
• Ability to manage, organize, and make decisions
• Three years direct monitoring experience or equivalent; combination of monitoring experience
• Three years direct oncology monitoring experience
• Have performed all visit types (site evaluation/selection, initiation, routine monitoring, and closeout)

Clinical Research & Medical Affairs Resume Examples & Samples

• 2 years of degree level study completed
• A minimum of 2:1 achieved in first year of study
• Bio science degree types only
• High level of accuracy and attention to detail
• Passion for working in the pharmaceutical/medical industry
• Highly analytical
• High level of scientific understanding and intellectual capacity
• Adaptable and able to work with a wide range of different personalities
• Excellent communication skills both written and oral
• Seeks opportunities to learn and grow professionally
• Able to prioritise and manage own workload autonomously
• Flexible and adaptable team player
• Self-motivatedClinical Research MD

Senior Assoc Clinical Research Resume Examples & Samples

• Participates in assessing performance data generated by R&D/Business Teams prior to initiation of the clinical study
• Prepares design validation plans that meet product design goals; intended use; regulatory requirements; divisional operating procedures; and Clinical Research work instructions
• Prepares clinical protocol; clinical brochure; case report forms; informed consents; and other required documents for clinical studies
• Identifies and qualifies clinical investigators and clinical sites
• Proposes and negotiates budgets for clinical studies. Initiates payments to sites
• Initiates clinical studies and provides for investigator and staff training
• Arranges for and assists Statistical Support with the collection and statistical analyses of clinical data
• Monitors clinical studies; ensuring site compliance with the clinical protocol and ICH/GCP guidelines; assures subject rights; safety; and welfare are protected; ensures data integrity through completeness; accuracy; and legibility
• Reviews data; prepares and presents clinical data reviews and data summaries
• Responds to audits and data queries representing a project or team
• Assists in presentation of clinical information to the FDA
• Initiates standard publication or presentation of clinical data in professional journals or meetings
• Functions independently in the field and interacts with all levels of medical and scientific professionals
• Assumes responsibility for attending training sessions; presentations; and continuing education sessions to expand professional expertise via professional and educational opportunities
• Serves as a resource person for most technical questions or directs inquiries to appropriate references
• Accepts and completes all management-directed work assignments such as clinical assignments; travel; and other tasks
• The minimum of a Bachelor’s degree and three to five years experience in clinical/translational research operations in any of the following areas: Academia, Pharmaceutical Company, Contract Research Organization (academic or private sector) or Site Management Organization (academic or private) or an equivalent combination of education and experience is required. Master’s degree preferred
• Direct experience in the following areas
• Development of protocols, consent forms, and case report forms
• Operational involvement in multi-site clinical trials
• Working knowledge of GCP regulations
• Working knowledge of CMS/GCP/ OHRP/FDA/HIPAA regulations

VP, Clinical Research Resume Examples & Samples

• Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across neurology and pain
• Direct authorship contributions in protocols and clinical study reports
• Lead and motivate clinical development medical staff
• Oversee hiring additional staff as needed
• Interact with senior management and serve as a standing member of various leadership meetings and Monthly Project Review forum
• Serve as a primary internal and external spokesperson for Alkermes neurology and pain clinical development programs
• Represent the company to external audiences in the clinical and pharmaceutical industry communities and organizations
• Generate yearly strategic goals and objectives for the group
• In collaboration with the clinical operations, oversee and coordinate the operational aspects of ongoing projects to ensure that goals of time, cost and quality performance expectation are met
• In collaboration with clinical operations, project management and finance staff, generate study and departmental budgets; complete other administrative tasks as required
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards
• Identify and develop collaborative relationships with key investigators and key opinion leaders globally. Attend and oversee neurology and pain clinical advisory boards and investigator meetings
• Critically review regulatory submissions (such as INDs and NDAs)
• Requires a Medical Degree and clinical training in Neurology
• Strong leadership and collaborative interpersonal skills
• 10 + years of experience in the pharmaceuticals. Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired
• Knowledge of safety reporting principles, including global safety reporting regulations
• Able to perform thorough reviews of various medical and legal documents in a timely manner

Clinical Research Associate, Budapest Resume Examples & Samples

• Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service
• Conduct monitoring activities independently
• Ideally 2 or more years of monitoring experience in interventional studies with a CRO, pharmaceutical or biotech company

Executive Director of Clinical Research Resume Examples & Samples

• Play a leadership role in managing multiples of Phase I through Phase IV clinical research trials across all functional areas of the drug development process
• Oversee and coordinate the operational aspects of ongoing projects to ensure corporate goals of time, cost and quality performance expectation are met
• Guide clinical operations in outlining standard operating procedures (SOP) for Clinical Development that facilitate the development of drug research protocols, compliance with clinical/medical standards and compliance with industry standards
• Lead and motivate clinical staff
• Develop and review protocols and interact with key external opinion leaders regarding protocol development
• Collaborate with investigators and study site team members
• Conduct investigator meetings and site visits
• Implement and supervise clinical trials, including requests for eligibility and other waivers
• Monitor clinical trial progress including, but not limited to, drug safety, assessments and tracking of patient safety and protocol deviations. Prepare SAE narratives for submission to regulatory affairs, reconciling SAE database, MedDRA and WHO coding
• Advise and troubleshoot any medical problems arising at clinical sites
• Interact with data management to support data entry including assistance with edits
• Demonstrate leadership and interpersonal skills
• Support commercial and marketing team for life-cycle management of approved products
• Participate in data analysis, publication preparation, and conference presentation
• Represent clinical development function for other teams’ need including business development and legal related projects
• Interact with senior management and product team regarding drug development strategy and plan
• Interact with investigators and key opinion leaders regarding protocol development
• Write protocols, IB and annual reports
• Contribute to Clinical Study Reports
• Write safety section of IND and NDA submissions
• Help prepare for budgets and progress reports; complete other administrative tasks as required
• Represent clinical development to support regulatory, safety, manufacture, data analysis and other business need
• Requires a Medical Degree with clinical experience
• Requires Hematology or Oncology experience and knowledge
• Three to 5 years’ experience in the pharmaceutical or contract research industries, or academic clinical research
• Knowledge of safety reporting principles, including FDA safety reporting regulations
• Skill in writing narratives
• Experience with safety database coding
• Able to work independently, prioritize tasks efficiently and meet expected time frames
• Able to perform thorough reviews of various medical and legal records in a timely manner
• Able to interact and collaborate professionally with various departments, regulatory agencies and investigators
• Forecasts, develops and implements policies and procedures in the areas of research compliance, human resources and budgetary goals and objectives that are consistent with University of Utah’s policies
• Develops and promotes new and existing policies, procedures and programs to internal and external functional groups
• Participates in oversight committees to establish compliance standards and administrative plans and policies
• Assures institutional clinical trials are conducted according to University and federal regulations as well as the NCI-approved Data and Safety Monitoring Plan through auditing and oversight of HCI’s Research Compliance Office
• Develops departmental strategies consistent with the department’s continuous quality improvement program
• Ensures competency of clinical research staff working in a complex and regulatory-rich environment through the development and/or presentation of educational programs

Manager Medical Writing, Clinical Research Resume Examples & Samples

• At least 5 years of experience writing clinical research documents
• May consider less experience with advanced degree
• Adept in Microsoft WORD

Clinical Research Associate, Greece Resume Examples & Samples

• Excellent standard of verbal and written communication skills in English language
• Highly organized with strong attention to detail and deadlines
• Advanced skills across all of the MS Office packages

Manager, Clinical Research Administration Resume Examples & Samples

• Set up and maintenance of program files for internal and external constituents
• Track third party Clinical Operations vendor agreements with respect to scope, quality, budgets, deadlines/milestones, communication, documentation/administration, and employee resources
• Assure departmental and corporate compliance with clinical operations SOPs; liaise with Quality Department to document adherence
• Prepare and support Committee Meetings as defined in the Sponsor and vendor contracts
• Work with the Finance Department to assure timely invoice processing support for external Clinical Operations vendors and consultants
• Prepare updates for Donor Development, Marketing and other LLS departments as directed
• Minimum of 5 years of project administration, management, or process improvement experience
• Bachelor's Degree required; Master’s Degree preferred with a focus in Project Management, Process Improvement, Business, and/or Operations or in a scientific field
• Laboratory experience in an academic or biotechnology setting preferred
• Experience with project management tools and software or ability to learn the software as needed
• Demonstrated organizational aptitude
• Proficient in Microsoft Applications; Excel, PowerPoint, Word

Clinical Research Data Associate Resume Examples & Samples

• Bachelor's Degree or equivalent work and/or life experience
• Proficiency in database and word processing skills, and MS Office
• Strong customer service skills and an ability to interact cordially with others
• Knowledge/experience with electronic data submission
• Provide direct oversight for all activities relating to the daily operation of the CDM team in the DCC including making project assignments and setting dates for completion with staff input
• Hire and directly supervise CDM I-IV staff members. Approve time and attendance
• Support staff in decision making, project planning and goal setting
• Communicate regularly with team; share information, provide relevant updates
• Complete evaluations and promote staff development and education opportunities as appropriate
• Develop and maintain high quality standards using documented processes and guidelines
• Function as a lead clinical data manager on cross-functional project team. The lead CDM is responsible for configuration of electronic data capture system, creation of data validation processes and checks, creating reports, and maintaining change control process
• Oversee initial design and implementation phase for unique network research projects
• Develop, evaluate and implement new systems and processes used in the management of clinical research information, e.g. medical imaging management systems, and processes for the management and validation of external data sources
• Act as internal resource for network directors and the director of the DCC to operationalize far reaching research goals and find realistic solutions to unique problems
• Implement creative solutions and innovative practices as applicable regarding data management practices
• Collect and label samples as instructed and deliver or process samples in accordance with the protocol, manual of operations, standard operating procedure (SOP) or other work instruction set
• In the course of biospecimen handling, follow Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Clinical Laboratory Improvement Amendments (CLIA) processes, UAHS and Banner procedures and/or other applicable policies as necessary
• Follow direction of research staff, investigators, or others involved in the clinical research project work
• Oversight of all sites for a study/ies they are responsible for at a country level
• Clinical research monitoring experience (minimum 2+ years) that provides the required knowledge, skills and abilities and experience mentoring or training others
• Effective clinical monitoring skills
• Good quality background and experience with healthcare or pharmaceutical development is required
• Must be driven to deliver quality results on time and in a highly ethical and professional manner
• Candidate must be willing to travel (up to 25-50%, potential more depending on enrollment). International travel may be required
• Great organizational and communication skills
• Proficient in use of Microsoft Office applications
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
• Ability to write routine reports and/or correspondence
• Ability to speak effectively before groups of customers or employees of organization and in a high pressure environment
• Track study timelines
• Review and track study budgets
• Provide periodic updates on Clinical Development
• Provide monitoring support, in some cases functioning as the primary site monitor
• Assist in writing and review of protocols, amendments, and informed consent forms
• Manage development of study-specific guidelines (Case Report Forms, Monitoring Plans, and Pharmacy Manuals, etc.)
• Perform investigative site training
• Review CRO, vendor, and internal SOPs to ensure consistency and proper delegation of responsibilities among study teams
• Assist in development of vendor relationships with CROs, drug depots, country-specific laboratories, and other vendors, as needed
• Ensure compliance with study-specific procedures
• 3-5 years of investigative site monitoring or study coordinator/study nurse experience
• Supports Principal Investigators (PI) and study management staff with patient screening/enrollment, eligibility review, data submission, and overall maintenance of new and ongoing clinical trials
• Ensures study management staff are providing quality source documents and data to sponsors, while ensuring protocol compliance is maintained within regulatory guidelines and standards
• Routinely monitor and ensure compliance with eligibility, protocol requirements, data submission completion while monitoring delinquency rates, outstanding query resolutions
• Manage standing team meetings to discuss issues related to the CRC/RDC team and clinical trial needs
• Ensure monitoring/auditing reports and outstanding issues with staff are identified, addressed, and resolved in appropriate timeframe while providing direction and oversight
• Contribute to developing educational materials on coordination and data completion processes and requirements for the teams, as well as evaluation and education tools to assess staff competency
• Coordinate with MDG and PIs to provide information on available or competing protocols, workload resourcing for team while providing primary point of contact support for completion of start-up activities (i.e., initiating CDA, Feasibility, MDG scoring and navigation of review committees required for activation, etc.)
• Prepare clinical research reports for PIs, MDGs, HCI Leadership and sponsors
• Provides transparent clear directives and constructive, professional communication with fellow Program Managers to promote uniformity across MDGs and within the CTO
• Actively attend and participate in representation of the Clinical Trials Office at MDG and RIP meetings for primary teams and as needed for other Clinical Program Managers
• Develop, implement and enforce Standard Operating Procedures (SOPs) & Work Practice Documents (WPDs)
• Oversee and ensure completeness in appropriate AE and SAE reporting requirements as well as Deviation reporting to sponsors and the IRB
• Facilitate cooperative and collaborative institutional relationships
• Ensures PI and MDG satisfaction by analyzing complaints, concerns and suggestions and providing appropriate follow-through
• OTHER: Assume responsibility for additional assignments as directed by the CTO Associate Director

Clinical Research Associate, Italy Resume Examples & Samples

• Qualified as per the Ministerial Decree dated 15/11/2011
• Ideally 2 years’ monitoring experience in clinical development phase II-IV
• Fluency in English and in Italian

Clinical Research Associate Senior Clinical Site Monitor Resume Examples & Samples

• 10+ years of pharmaceutical development experience with at least 5 years of advanced site monitoring/management in complex small molecule and biologic trials in a wide array of diseases (oncology, transplant, HIV, etc.) across the development spectrum (phases I-IV)
• At minimum a Bachelor of Arts or Science, or equivalent, in health related field from an accredited institution
• Thorough technical working knowledge of Remote Data Capture, EMR and computer based systems
• Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision making skills
• Identifies innovative solutions to accomplish objectives while maximizing utilization of budget, resources and time
• Ability to successfully manage the designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary

Clinical Research Coor Resume Examples & Samples

• Coordinates daily operations of clinical research studies in Neurology to include assisting Chair & PI(s) with maintaining performance reports, bio-sketches, statistics, analyzing grant development & submission
• Recruit, enroll, assess, and track participants as they complete protocols for various Neurology studies. Assist Chair & PI in coordinating and performing a wide variety of research related functions including assessments data collection, data entry, interpretation of data and data analysis, collecting blood and biological samples. Must be proactive and timely in all areas of trails; including developing marketing materials for new clinical studies, preparation of study initiations, screening and scheduling study subjects, getting subject consents, and teaching subjects about protocol expectations
• Facilitates IRB applications for submission and review
• Assist in pre-award budgets for all faculty related research projects. Assist in monitoring and management of budgets for all research projects to include completing all associated forms
• Must maintain accurate records and relevant collection of data to assigned patient to include communication, correspondences, and maintenance of pertinent documents related to research
• Other duties as assigned to include any research trainings

Clinical Research Associate, MDS Anemia Resume Examples & Samples

• With oversight, assist in the management of a region for a study or studies
• Assist in the preparation of investigator meetings
• Assist in meetings or conference calls with CROs and multi-disciplinary study team
• Assist in some aspects of vendor oversight (CRO, Central Lab, Central IRB, IWRS)

Clinical Research Coordinator Associate Resume Examples & Samples

• Some knowledge of psychopathology and psychiatric terms is desired
• The candidate must possess the necessary patience and resourcefulness to interact well with psychiatric patients, especially children, and their families
• Basic statistical skills

Lymphoma Clinical Research Liaison A Resume Examples & Samples

• Provide clinical support by quickly and accurately transcribing essential clinic or patient information onto electronic reports as the PI speaks with patients in real-time; check reports for correct punctuation and grammar errors, if any
• Manage the PI’s calendar, including facilitation of appointments, meetings and conference calls, as well as assistance booking traveling, creating trip itineraries, processing of reimbursement, and attendance of meetings and conferences as requested
• Prepare/format written correspondence on behalf of the PI, ensuring that all correspondence and other written materials and presentations are accurate and prepared in a timely manner
• Act as a liaison with various external and internal constituencies on behalf of the PI keeping him apprised of issues and action items on his agenda; establish good working relationships with research partners, research sites, and affiliated organizations
• Perform comprehensive literature, database and web-based searches with writing of summaries of findings as requested
• Assist with development and preparation of project-related reports, manuscripts, clinical concepts, research study protocols, and presentations
• Assist with any relevant submissions to ensure timely adherence to important deadlines, collection, processing and assistance in the compilation and verification of research data, create graphs/figures for data presentations and publications
• Other duties will be performed for the PI, PM or LCRN as deemed necessary and important

Associate Director of Clinical Research Operations Resume Examples & Samples

• Bachelor’s degree in a field appropriate to the area of assignment
• Eight or more years of related research experience implementing clinical research protocols including clinical trials and/or cohort studies
• Three or more years of supervisory experience
• Master’s degree in a field appropriate to the area of assignment
• Desire to serve a lively and diverse research community
• Strong organizational, analytical, and problem­-solving abilities
• Demonstrated skills in leadership and team-­building
• Bachelor’s Degree or equivalent in a scientific field of study and four (4) years related research experience
• Knowledge of Good Clinical Practice (GCP)
• Valid Driver’s License and acceptable driving record at the time of hire
• Two (2) years previous supervisory experience
• Research Nurse certification and at least two years of prior clinical research experience are required
• Six (6) years of prior research experience
• Master’s degree in Public Health or Healthcare Management is desired
• Proficiency with information systems and experience investigating costs related to clinical research trials
• Knowledge of IRB and policies and procedures
• Strong ability to organize, prioritize, and coordinate multiple activities to meet deadlines

Clinical Research Rn-targeted Therapeutics Team Resume Examples & Samples

• Collaborates with the clinical team in developing all aspects of patient care
• Assesses patient’s pertinent health history
• Experience: R.N. with a minimum of 1 year of RN experience
• Bachelors of Science in nursing (BSN)
• Knowledge of common pharmaceutical terminology

Medical Director, Oncology Clinical Research Resume Examples & Samples

• Clinical Development team participation and leadership
• MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned)
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions
• NDA/MAA/Submission experience preferred
• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities
• Therapeutic area knowledge relevant to mechanism of action
• Regional/global Regulatory requirements
• Emerging research in designated therapeutic area

Associate Director of Clinical Research Resume Examples & Samples

• The successful candidate will have oversight for ongoing and planned product trials within the Inflammation therapeutic area
• The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
• Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections
• Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
• Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff
• Assists in the clinical evaluation of business development opportunities
• The successful candidate will have oversight for ongoing and planned product trials within the Liver Disease therapeutic area
• The Clinical Research MD will report to a more senior member of the Liver Disease clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities
• Three (3) to five (5) years experience with a proven success record in clinical research studies and trial design is required
• Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices
• Experience in Liver Disease drug development
• Ability to think analytically and strategically to formulate, develop, and execute clinical plans
• Strong leadership skills with an ability to set vision, lead change, and mentor others
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving
• Excellent scientific written and oral communication skills
• Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
• Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
• Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected)

Site Clinical Research Associate Study Start Resume Examples & Samples

• Assist with the start-up activities of new clinical trials across Australia and New Zealand
• Assist in CSMS activities and/or reporting of study information and metrics
• Responsible for compliance with applicable Corporate and Divisional Policies and procedures
• Assist in completion of activities required for planning and execution of a clinical study
• Assist in the planning and submission strategies to ensure sites can open our clinical studies as soon as possible
• Assist in study activities such as preparation of protocol and informed consent, investigator/site selection, investigator meeting and contract preparation, and other activities to ensure on time completion of studies
• Assist in negotiation and execution of study budgets and contracts with study sites
• Participate in all study activation activities
• Assist in driving efficiencies within the start-up function
• Prioritize activities to ensure study timelines are met
• Study Contributor
• Assist in development of study/site budgets and vendor contracts
• Requires moderate level of oversight and guidance

Prin Clinical Research Spec Resume Examples & Samples

• Experience working with Health Authorities around the world, specifically PMDA
• Ability to supervise others over the execution of a trial
• Customer focusedComputer skills (MS Office products, word processing, spreadsheets, etc.)
• Ability to independently lead a study team and trial with little supervision
• Excellent understanding of biostatistics and trial design
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 and 14155:2011

Clinical Research Medical Director Resume Examples & Samples

• Provide medical expertise specific to US
• Provide consolidated feasibility and site selection input to global and US teams
• Perform local AE review and provide general medical support for safety issues
• Be aware of clinical trial SAEs on a country level
• Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials
• Support ICRO/ and Global teams in interaction with regional regulatory agencies
• Provide assistance to ICRO and site for IEC/IRB Interactions
• Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care
• Demonstrates a high level of understanding of the protocol to train others on the protocol including site personnel where applicable
• Demonstrates understanding of the protocol to evaluate investigator / site patient protocol compliance and patient safety
• Ability to manage a study from the medical perspective, and a demonstrated capability to problem-solve and mediate complex medical / operational issues within the regional and therapeutic area context
• A minimum of two years pharmaceutical industry or clinical trial management experience required
• Manage clinical trial documentation such as CRFs (case report forms) and DCFs (data clarification files) within Data Management. This activity includes distributing DCFs, tracking and filing of DM project documentation
• Interact with CDM staff, management, and other project team members to resolve issues and provide status information
• Assist Data Operations Coordinator/Data Team Lead in the creation and maintenance of the Data Management Study File and Data Management Plan (Data Tracking Guidelines) and other project files

Clinical Research Application Specialist Resume Examples & Samples

• Bachelor’s degree in Clinical Research, Science, Health Sciences, Information Technology, Business or related field
• One year experience working with web-based applications/information systems in a healthcare, finance, or other highly-regulated environment
• Prior experience in building calendars with OnCore at an academic medical center is preferred
• Experience with other CTMS or financial data systems in support of clinical research is desirable
• Experience providing technical support to customers
• Demonstrated knowledge of study design criteria, randomization processes, clinical and bio-specimen terms used in research studies, and scientific and medical concepts and terminology
• Knowledge of Federal and Institutional confidentiality policies applicable to electronic databases containing protected health information and data collected specifically for research
• Knowledge of medical billing terms and research billing operations for industry, institutional and national group -sponsored research
• Diplomatic disposition and customer service orientation with excellent written and verbal communication skills
• Detail-oriented self-starter with outstanding interpersonal skills, and a reputation for establishing and maintaining good customer and end-user relations
• Comfortable asking questions, working with minimal supervision, and collaborating with coworkers in a team environment on complex projects
• Quick and agile learner, able to adapt to changes in technology and its intended use
• Able to synthesize complex clinical trial information in order to facilitate decision making
• Proficiency in Microsoft Windows and Office, including advanced skills in Excel
• Familiarity with terminology and processes associated with all phases of clinical research

Group Head, Clinical Research Resume Examples & Samples

• Lead or oversee the creation of clinical strategies and clinical development plans for assigned programs across development phases, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
• Manage, oversee and develop Clinical Research direct reports, building the group’s capabilities in support of the needs of our evolving development portfolio. Coach, train, and/or mentor employees to optimize their performance
• Identify program issues and develop sound strategic solutions with clinical teams to ensure their timely resolution
• Be the recognized clinical expert for assigned development program/s both within and external to Ironwood
• Provide medical input into the design of clinical trials for these development programs. The Clinical Research group will design scientifically rigorous and cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices
• On assigned programs, serve as a medical monitor for clinical studies (provide medical oversight of the study; address eligibility questions; review safety and adverse event information), working closely with cross-functional team members, including external partners, to ensure planning and execution of high quality clinical trials that meet key milestones, maintain timelines and keep within budget
• Assist in the preparation of clinical protocols and Regulatory documents (eg., INDs, annual reports, FDA/EMA meeting requests, briefing books, and NDAs) and other relevant clinical documents
• Provide authoritative clinical leadership in preparation for and interactions with Regulatory Authorities
• Contribute actively to the Clinical Affairs leadership team, relevant governance bodies, and process improvement initiatives
• Collaborate effectively with other members of the Clinical Affairs and broader R&D teams on medical matters related to drug development
• Provide clinical, scientific and development expertise to business development projects and diligence
• An MD or DO degree, with internal medicine expertise
• Eight or more years of pharmaceutical/biotech-industry experience in clinical research and development, ideally with experience across Phases 1-3, through registration, and post-approval
• Strong strategic thinker who can provide vision and purpose for teams and a drive for results
• Possesses thorough understanding of operational aspects of clinical research and development
• Strong general knowledge of regulatory requirements, including principles of GCP, ICH and CFR, that apply to clinical development, with significant experience interacting directly with Health Authorities
• Three or more years of people management experience, with demonstrated ability to motivate, mentor, develop and lead other physicians in clinical research
• Able to set priorities for team, establish clear direction and objectives and maintain accountability
• Excellent ability to lead and work in cross-functional teams with a collaborative style that builds alliances and emphasizes integrity, results, collegiality and effective teamwork in a fast-paced and changing environment
• Persuasive, effective and flexible in interpersonal interactions at all levels, with outstanding oral and written communication capabilities
• Effective relationship management skills with internal and external partners
• Strong analytical, decision-making, project management and problem-solving skills
• Specialty training and board certification, or expertise in gastroenterology, rheumatology or nephrology would be ideal, but is not required

Clinical Research Coordinator Pediatric Anesthesia Resume Examples & Samples

• Demonstrated clinical and/or research experience in Anesthesia and/or Pediatrics
• Knowledge of EPIC based electronic medical record systems
• Experience in clinical trials management, including writing and submitting IRB applications, protocol revisions and consent

Clinical Research Operations Manager Resume Examples & Samples

• Extensive experience in clinical research as a coordinator, research nurse, data manager or clinical project manager
• CCRC certification, excellent knowledge of Good Clinical Practices and Regulatory requirements for clinical research studies
• Demonstrated leadership and supervisory skills including conflict resolution
• Strong financial expertise in accounting, budget planning and financial forecasting
• Strong expertise in grants and contract administration
• Strong negotiation and interpersonal skills
• Strong knowledge of industry standards and/or regulatory requirements

Non-clinical Research Protocol Manager Resume Examples & Samples

• Minimum of 7 years work experience within the pharmaceutical industry
• Knowledge of preclinical/nonclinical research
• Demonstrated Excel and analytical skills
• BA/BS degree in a life science field
• US military experience will be considered towards industry experience requirements

Clinical Research Associate Trainee Resume Examples & Samples

• Gain experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Team Lead (CTL) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as data management and pharmacovigilance
• Under close supervision, perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to CTL and/or line manager
• Under close supervision, manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
• Basic knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
• Strong written and verbal communication skills including good command of English language
• Excellent organizational and problem-solving skills
• Ability to manage competing priorities

Clinical Research Associate, Oncology Resume Examples & Samples

• You will be responsible for ensuring that, at the site level, the Clinical Monitoring Plan is implemented
• Excellent knowledge of Good Clinical Practice (GCP) and also good working knowledge of conducting clinical trials in general
• Experience of performing site start up procedures, routine monitoring and site closure

Manager of Clinical Research Resume Examples & Samples

• Education: Bachelor's degree required. Degree in health sciences or business preferred
• Experience: Minimum of five years’ experience in clinical research required. Customer service experience in a medical office or hospital setting preferred
• Licensure/certification/registration: National Research Organization required

Director, Regional Clinical Research Resume Examples & Samples

• Consistently exhibits behavior and communication skills that demonstrate HealthCare Partners’ (HCP) commitment to superior customer service, including quality, care and concern with each and every internal and external customer
• Attends educational workshops
• Review professional publications
• Participates in professional societies
• Proficient in Microsoft applications
• Contacts with pharmaceutical companies and clinical research organizations

Manager of Cardiology Clinical Research Sites Resume Examples & Samples

• Knowledge of organizational policies, standard operating procedures and systems
• Public presentation skills
• Interpersonal skills
• Cardiology experience
• Management experience
• Supporting the development, execution and communication of the global scientific/medical evidence plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Supporting the development of key scientific external relationships with opinion leaders
• Participating and providing clinical input into safety and regulatory interactions
• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Sound scientific and clinical judgment
• Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Two (2) or more years of clinical research experience and/or basic science research
• MD plus accredited residency in relevant sub-specialty, board certified or equivalent
• Five (5) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

Clinical Research Study Leader Resume Examples & Samples

• Leads the cross-functional Study Management Team (SMT). In the SMT Leader (SMTL) role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting. The SMTL is accountable for the delivery of the clinical studies within the agreed timelines, budget and quality
• Prepares and manages the budget/financial plan including overall study and site-level costs, collaborating with the respective stakeholders in contract negotiations and preparation, payment schedule and tracking
• Identifies key milestones and tracks critical study activities, issues and strategic priorities. Provides regular updates as appropriate, to key stakeholders
• Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site selection, initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
• For outsourced studies, contributes to CRO selection activities and contract set-up, serves as primary contact with CRO PM and provides oversight of CRO, ensures communication between CRO, other vendors and SMT for the entire study lifecycle
• Assures consistency and standards across a study or studies for all investigational sites and in line with project standards

Clinical Research Coordinator Ophthalmic Resume Examples & Samples

• Ideal candidate will have prior working in clinical research, with a specific emphasis on project management, either as a clinical research coordinator or regulatory coordinator
• Professional clinical research certification (ACRA or SoCRA) is desirable but not required
• Prior experience within ophthalmology, or prior ophthalmic technician training / certification is NOT required

Senior Director of Clinical Research Resume Examples & Samples

• A minimum of a Bachelor’s degree in Biological Science or related discipline, with a minimum of 10 years related scientific / technical experience, including leadership / management role within Clinical Research for at least 8 years
• With a PhD or Masters, these requirements would be a minimum of 8 years related scientific / technical experience, with at least 6 years of management within a Clinical Research role
• People management experience is required
• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations is required
• Ability to build and lead a team of scientists to provide scientifically rigorous strategic and scientific clinical research input across NPD and LCM projects is required
• Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations is preferred
• Comprehensive understanding of clinical trial regulations across multiple regions is required
• Ability to lead teams to deliver critical milestones is preferred
• Ability to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives is preferred
• Demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders is preferred
• Experience in effective management of platform budget processes is preferred
• Neurovascular experience is preferred.Clinical Research non-MD
• Clinical Project& QualityManagement
• Conduct site qualification including analysis and recommendation, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes
• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
• Minimum of 1 year of clinically-related experience, of which 6 months must be in clinical research monitoring [R1]
• Demonstrated strong site management and monitoring skills
• Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Good written and verbal communication skills both in English and in the local language
• Exhibit high degree of flexibility when facing changes in the work environment
• Previous experience with electronic data capture systems desirable
• Strong ability to work independently with minimal supervision
• Supporting the development, execution and communication of the global scientific evidence plan
• MD plus accredited residency in inflammation or oncology, board certified or equivalent
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO)
• In-depth understanding of clinical development and concepts of clinical research and clinical trial design, including biostatistics
• Leads the cross-functional Study Management Team (SMT). In the SMTL role, the CRSL is responsible for the planning, coordination, communication, motivation and setting the direction of the SMT, including obtaining agreement on study required timelines, budgets, objectives and goal-setting
• With SMT partners, ensures the development of study protocols in conjunction with SMT members, case report forms (CRFs) with Data Management, and necessary regulatory documentation following the provision of clear objectives
• Conducts protocol and site feasibility assessments to ensure optimal site selection
• Accountable for all aspects of study management including supply management, biosample management, vendor selection and management, site initiation, training, monitoring, essential document management, closedown and archiving in accordance with current Standard Operating Procedures (SOPs) and ICH Good Clinical Practice (GCP) guidelines
• Proactive management of all aspects of the study
• Manages both internal and external partners
• Works with Pharma Development Quality Assurance as appropriate to ensure that studies are conducted to appropriate levels of quality
• Ensures that all adverse events are documented and that serious adverse events are processed and reported according to current SOPs
• Reviews study data listings for accuracy, discrepancies and formatting throughout the study and prior to inclusion in regulatory documentation and clinical study reports
• CRSL may provide support and mentoring to other CRSLs
• Where appropriate, accountable to DBPT for planning, tracking and managing the operational budget, resources and timelines for the project against the agreed goals of the team
• Familiarity with Breast Cancer resources in the Bay Area is a plus
• Experience with recruitment of research participants for clinical studies
• Familiarity with EPIC is a plus
• Advanced Degree
• Board Certified Behavior Analyst
• Experience in working with children with intellectual disabilities and teaching social skills

Clinical Research Coordinator Healthcare Resume Examples & Samples

• To serve as coordinator for both single and multi-center, investigator initiated and industry sponsored, clinical studies, with responsibilities to include participant recruitment and retention efforts, medical record data extraction, data entry, and management of IRB and other regulatory matters related to clinical research under the instruction and direction of investigators
• Requires Bachelor degree in a science or health-related field or equivalent education and experience
• Extensive experience with successful submissions to IRB

Clinical Research Finance Manager Resume Examples & Samples

• BA/BS degree with a major in a health or business related field and 5 years of applicable experience or an equivalent combination of education and experience required
• Strong, proven experience as a supervisor required
• Strong working knowledge of CPT coding and medical terminology required
• Basic understanding of third party payor and sponsor reimbursement policies and standards of practice
• Computer proficient – must have strong Excel, Word, presentation, and database skills
• Ability to effectively collaborate with multiple departments and a strong team work ethic
• Ability to work independently with self-motivation and initiative
• Strong organizational and analytical skills and attention to detail

Clinical Research Analyst Resume Examples & Samples

• 2+ years of clinical coding experience
• 3+ years of relevant analytics experience
• 3+ years of healthcare or pharmaceutical industry experience
• Knowledge of health care claims, products, data and systems
• Preferred experience in working in a data warehouse environment as well as the ability to work with large data sets from multiple data sources
• Experience of project work, specification and testing
• SQL/SAS programming skills (e.g., SAS Base, SAS STAT, SAS Macros)
• Knowledge of analytic programming tools and methods (SAS, SQL, OLAP, Business Objects, Crystal)
• Two up to four years of clinical monitoring experience (including pre-study, initiation, routine monitoring and close-out visits)
• Oncology experience would be a plus
• Good communication, planning, organization and problem solving skills
• Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
• Completing Serious Adverse Event (SAE) reporting, processing production of reports
• Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned
• Assist with training, mentoring, and development of junior employees, e.g. co-monitoring (for CRAs II and SCRAs)
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs)
• Fluency in Czech and English language
• Recruiting potential investigators, working with start-up department for EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor
• Minimum 1 year of monitoring experience in pharmaceutical or CRO industries
• Fluency in local and English language

Clinical Research Resume Examples & Samples

• Directs and oversees Clinical Development/Operations and Regulatory Affairs process for a research and development services provider conducting clinical trials of experimental vaccines and biologics
• Develops study protocols and creates standards and guidelines for clinical research services and programs
• Ensures adherence to standard operating procedures, good clinical practice and FDA regulations
• Coordinates inspection of the organization and contract facilities, and coordinates regulatory submissions and Agency interactions
• Active/current Secret clearance is required (interim Secret is also acceptable)
• Master’s Degree with at least 12+ years of experience in the field is required
• Familiarity with a variety of the field's concepts, practices, and procedures
• Must rely on extensive experience and judgment to plan and accomplish goals
• Must have a wide degree of creativity and latitude
• Must be willing to travel occasionally
• PhD with 9+ years of relevant experience

Clinical Research Administrative Director Resume Examples & Samples

• Maintains investigational drug and drug accountability adhering to all NIH, NIAID, NINDS and other applicable federal pharmacy guidelines
• Maintains copies of each protocol that is IRB approved including all subsequent amendments and versions while adhering to all institutional and federal guidelines
• Maintains copies of the first and last pages of signed current informed consents that have been approved by the IRB for each protocol
• Maintains all current FDA form 1572s and Investigator of Record (IoR) forms and signature pages
• Ensures that outpatient dispensing is done according to guidelines in the most current IRB approved version of all protocols
• Liaises with protocol principal investigators to establish pharmacy’s role in the trial for study drug compounding, packaging, and dispensing
• Liaises with external agencies/organizations, as required
• Monitors pharmacy activities to ensure adherence to study protocols and dispensing procedures
• Communicates with, and trains staff anticipated to participate in any aspect of the clinical investigational drug trial
• Maintains a pharmacy binder (paper or electronic) which contains a study summary, protocol, dispensing procedures, dispensing checklist, and any other relevant materials for each investigational trial
• Available by prior scheduling request to dispense medications if needed for after-hours
• Maintains investigational drug inventory
• Performs an ongoing perpetual inventory and a monthly total inventory of all investigational products
• Responsible for correct ordering, storage, dispensing and return of investigational agents according to IRB, state and federal (NIH, FDA) requirements
• Maintains investigational research database for assisting with drug accountability, dispensing and return of investigational products
• Attends bi-weekly staff meetings
• Participates in all new study start-up meetings
• Serves as an educational resource to study participants and other staff regarding drug dispensing, dosing allowed concomitant medications, and drug interactions with non-study medications, other dosing requirements (food effects, etc)
• For each research study, correctly stores, dispenses, and records investigational product according to sponsor’s instructions, participant’s randomization; maintains study blinding where appropriate
• Orders new study-specific inventory in a timely fashion so that study drug administration is uninterrupted
• Returns unused study drug to sponsor according to study-specific requirements
• Cooperates with study monitors during site visits to facilitate oversight on study drug storage, dispensing and accountability
• Constructs and maintains Pharmacy Plan and all standard operating procedures as needed for the investigational pharmacy
• Completes all required research training and maintains certificates of Good Clinical Practice and Human Subjects Protection as required by institution, State and Federal Agencies (e.g., NIH, FDA, OHRP)
• Maintains Ohio Pharmacist license in accordance with Ohio State Board of Pharmacy
• Maintains Ohio Pharmacy License for the Clinical Trials Research Pharmacy in accordance with the Ohio State Board of Pharmacy, including required text books
• Supervises research pharmacy technician as required. Delegates work assignments and checks work orders filled by technicians
• Fulfills all requirements to serve as StrokeNet National Coordinating Center Central Pharmacist
• Coordinates time off with back up pharmacist
• Attends annual ACTG, HPTN, StrokeNet and other Network meetings as required
• Ohio License from State Board of Pharmacy
• RPh or PharmD
• Ability to Obtain Independent Pharmacy Licensure from State Board of Pharmacy
• Eligibility to apply for an institutional DEA license
• Eligibility to apply for a wholesale license
• Meticulous documentation skills
• Previous experience with investigational drug management preferred but not required

Clinical Research Monitor Based Inspain Resume Examples & Samples

• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Excellent problem solving skillS
• Experience of conducting clinical research activities in a regulated environment

Clinical Research Senior Program Resume Examples & Samples

• Bachelor's Degree, preferably in a Business, health-related, scientific or engineering field
• Minimum 4 years of experience within a Business Analyst and/or project management role (2+ years with Masters or Doctorate degree)
• Project Management Certification (preferably PMI) - preferred
• Green Belt Certification – Ongoing use of Six Sigma tools (Process map, C & E, FMEA’s, Risk Analysis, etc.) - preferred
• Able to clearly communicate with all levels of management while collecting business needs and requirements
• Proficient in MS Office Suite of Products; Word, Powerpoint, Visio, Project (ex: customization of fields, tables, views; modifying reports; analysis of critical path.) and Excel (ex: pivot charts, vlookups, graphs, truncating text, etc.)
• Applied knowledge of project management tools and processes (e.g. management of integration, scope, time, cost, quality, human resources, communications, risk, procurement, and stakeholders as defined by Project Management Body of Knowledge)
• Enthusiasm towards process improvements and change management
• Excellent oral and written communication skills; able to communicate clearly and succinctly with team members and leadership
• Strong problem-solving skills; able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team
• Excellent self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
• Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback
• Flexibility to adjust quickly and effectively to frequent change and altered priorities
• Candidates with work experiences in pharmaceutical, medical devlice and/or CRO industries are preferred
• Practical experience performing project management for a cross-functional project
• Critical chain project management certification or experience with application of critical chain project management principles

Clinical Research Associate, Dcri-outcomes Resume Examples & Samples

• Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. two years directly related clinical trials research experience; or
• Completion of a bachelor's degree plus a Minimum of three years directly related experience in clinical trials research; or
• Completion of a bachelor's degree plus a minimum of four years closely related research experience

Clinical Research Coor-clinical Research Institute Resume Examples & Samples

• Develop and maintain relationships with faculty members interested in or currently conducting clinical research
• Develop and maintain relationships with assigned pharmaceutical, medical device, and other medical manufacturers considering clinical trials
• Actively market the Clinical Research Institute
• Facilitate IRB application and submission via iRIS system
• Facilitate ongoing and timely communication with the IRB via iRIS system
• Recruit and enroll human subjects while protecting subjects and subjects’ rights
• Maintain Study files/documents on all assigned studies
• Facilitates data quality and integrity
• Assist with development and management of research study budget
• Assist faculty/staff with development of research protocols
• Assist with clinical research education and training of volunteers, students, new employees
• Attend affiliated clinical research meetings and professional meetings where research and compliance training may occur
• Obtain SoCRA (CCRP) or ACRP (CCRC) certification when eligible
• Maintain CPR certification
• Maintain IATA training/certification
• Maintain required institutional training to be able to participate in Clinical Research activities (i.e. CITI and HIPAA research training)
• Obtain/Maintain ACLS certification
• Participate in the Clinical Research call schedule rotation as needed
• Obtain and maintain appropriate credentialing approval from University Medical Center's Medical Staff office
• Healthcare related training with current licensure/certification in their field. OR
• Bachelor's degree from an accredited university with a major in the area of research being conducted

Specialist Clinical Research Resume Examples & Samples

• Reviews protocol and Case Report Forms (CRFs) during the development process and contributes to enrollment /randomization/blinding procedures
• Serves as a Clinical Trial Systems Administrator for related system functions including study configuration and assures appropriate study integration
• Responsible for initiating timely payments to the sites and communicating with Clinical Planning/Finance
• Monitors study progress and routinely interacts with study team members and management to inform them of PSM issues that may impact study milestones
• Works closely with study site personnel to resolve issues, e.g. payments, supplies, enrollment/randomizations, product accountability
• Performs randomization, product accountability and supply reconciliation for assigned studies
• Manage research supplies and related study needs including permission of tools/questionnaires, clinical file archiving
• Assure management and control of product throughout lifecycle
• Responsible for conducting assigned responsibilities in compliance with applicable Abbott Policies and regulations
• Participates in various organizational committees and develops work flow process improvements for department procedures
• Plays an active role as trainer for purposes of cross-training or for educating new PSM employees; often assists with formal or informal training of study personnel and study team members outside of PSM regarding roles and responsibilities
• Serves as a PSM subject matter expert for study teams and cross functional stakeholders understanding of research processes
• Flexible, well organized, and strong communication and interpersonal skills
• Works well under pressure, with initiative to take on unfamiliar tasks
• Basic and some advanced computer skills (includes word processing, spreadsheets, instrumentation related to Abbott network systems and advanced technical software)
• Team oriented, with high energy and desire to achieve results. Ability to work in multidisciplinary teams and meet business goals
• BA in health profession or scientific related field preferred
• 0-5 years’ experience in the clinical research industry preferred
• Knowledge of Good Clinical Practice and research industry standards preferred
• Proficiency with clinical systems and/or experience with clinical trial management systems preferred
• MD plus accredited residency in relevant sub-specialty
• Board certified or equivalent
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in Neuroscience
• Strong background in neurodegenerative diseases with expertise in AD highly preferred

Clinical Research Quality Auditor Resume Examples & Samples

• A Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
• At least 3 years in clinical research in industry or academia
• Proven auditing ability
• Demonstrated ability to prioritize own work and multi-task
• Ability to routinely and independently exercise sound judgment in making decisions
• Relevant subject matter knowledge

Rwlpr Clinical Research Associate Resume Examples & Samples

• Directing and managing the delivery of all required start-up, maintenance and regulatory activities for selected studies as determined by either the agreed algorithm or the Sponsor’s (customer’s) requirements
• This includes pre-award activities, oversight of the scope of work, budget and resources
• Developing and implementing the RSU Management Plan
• Ensuring collaboration across RSU, including communication with regions and countries
• Assisting with the creation and review of core scientific, technical and administrative documentation
• Contributing to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence
• Ensuring overall project efficiency and adherence to project timelines and financial goals
• BA/BS or MA/MS
• Experience with social science research and/or clinical trials
• Knowledge of eating disorders
• MRI/fMRI collection, processing and analysis, and interpretation
• Maintain research appointments calendar
• Writing programing scripts to streamline data processing and analysis
• Assist in making appointment reminder calls to research participants
• Cancel and reschedule appointments as needed
• Place research notes in MiChart as needed
• Perform general office and administrative duties as assigned
• Other duties as directed by the Principal Investigator
• Bachelor’s degree in Neuroscience
• Computer proficiency (e.g. Microsoft Word, Excel, Power Point and EndNote), including programming languages (i.e., Python, FreeSurfer, R, Matlab, Swift, C & Git)
• Extensive experience (5+ years) with processing and imaging analysis platforms such as Freesurfer, FSL, and SPM
• Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
• Previous experience working on fMRI analysis
• Outstanding organizational skills with meticulous attention to detail
• Proven ability to work independently with minimal supervision
• Ability to problem-solve and establish timelines and priorities
• Available to work some evenings and weekends as necessary
• Ph.D. degree in Neuroscience with post-doctoral training on brain imaging and biomarkers
• Experience working with older adults and veterans
• Experience working and interacting with research participants
• Experience with Electronic Data Capture
• Proficiency in using statistical analysis packages such as SAS and SPSS or other research laboratory programs
• A working knowledge of medical terminology and assessment of laboratory values
• Additional Information

Clinical Research Assoicate Resume Examples & Samples

• Must possess 2+ years of oncology experience
• Experience in monitoring clinical trials required
• Strong written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions
• Ability to reason independently and recommend specific solutions in clinical settings
• Understand current GCP/ICH guidelines applicable to the conduct of clinical research
• Valid driver’s license; ability to rent automobile

Field Clinical Research Associate, Senior Resume Examples & Samples

• Strong preference for prior clinical monitoring experience
• A general familiarity with cardiac, vascular, and/or neuromodulation technologies Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
• Certification by an industry-recognized professional society (i.e. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or accredited institution
• Management of clinical research studies including patient screening and enrollment; study medication accountability; database management; coordination of study visits, labs and procedures; documentation and communication with physicians, study coordinators and sponsors
• Coordinates the submission of clinical study materials to IRB and other regulatory agencies for approval
• Collects specimens and monitors subjects. Assists in the reporting of tests results
• Attend investigator and coordinator meetings
• Serve as a resource and contact person for active protocols
• Critique study protocols and assist with budget
• Bachelor’s degree or equivalent professional degree and documented 5 years’ clinical research experience
• Ability to communicate effectively and follow written and verbal instructions
• Demonstrate strong analytical and organizational skills, including high level accuracy and attention to detail while exercising good judgment
• Proven ability to set priorities, exercise initiative, work simultaneously on numerous projects and meet/negotiate deadlines
• Ability to effectively work with diverse teams as well as independently
• Demonstrate efficient organizational skills and ability to effectively problems solve and implement solutions to improve processes
• Excellent interpersonal and conflict resolution skills
• Takes initiative in process improvement and functions in self-directed manner and demonstrated willingness to be flexible where needed
• Understanding of IRB and applicable regulatory guidelines
• Proficient use of computers and applications including Microsoft Word, Excel, PowerPoint, EndNote, Microsoft Access and SPSS
• SOCRA certification
• Knowledge of and experience with UMHS basic research, ULAM and UCUCA policies and procedures
• Prior experience with laboratory administration and finance

Assistant, Clinical Research Resume Examples & Samples

• A minimum of an Associate Degree with minimum 2 years of industry experience is required or H.S. diploma with a minimum of 8 years of industry experience required
• Previous experience with study coordination is preferred
• This position may require up to 10% domestic travel
• This position is required to be based in Skillman, NJ.Clinical Trial Coordination
• Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas
• Implements appropriate activities to ensure the site meets the enrolment target within the agreed timeline
• Report monitoring activities and study site conduct accurately and completely
• Proactively identifies issues that may impact enrollment and recruitment timelines, and provide objective comments regarding these issues
• Supports remote monitoring, if and as applicable
• Undergoes and maintains training as required by Global Clinical Operations and other relevant company procedures, to ensure adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
• Candidate should be located in Missouri
• Exhibits high degree of flexibility when facing changes in the work environment. Attention to detail and strong interpersonal skills
• Previous experience with electronic data capture systems is desirable

Clinical Research Asssociate Trainee Resume Examples & Samples

• Complete appropriate therapeutic, protocol and clinical research training to perform job duties
• Gain experience in study procedures by working with experienced clinical staff
• Under close supervision, perform site selection (if applicable), initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices
• Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer
• Bachelor's degree, preferred in health care or other scientific discipline; or equivalent combination of education, training and experience

Neuroimaging Clinical Research Coordinator Associate Resume Examples & Samples

• 2-3 years of related experience in subject recruitment, assessment, and analysis related to brain imaging research
• Technical experience in running MRI scans
• Proficiency with basic programming and scripts
• Desired experience in
• Neuroimaging analysis with extensive experience with analysis toolkits and frameworks: SPM, FSL, AFNI, Nipype, Freesurfer, Murfi (Multivariate and Univariate Realtime-fMRI imaging), open fMRI
• Experience in Cognitive experiment stimulus creation: E-Prime
• RedCap experience desired

Clinical Research Associate, Device Resume Examples & Samples

• Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA
• Attends study-related, company, departmental, and external meetings, as required
• Ability to handle several priorities within multiple, complex trials

Clinical Research RN Phase Resume Examples & Samples

• May be called upon to perform the following specific tests and procedures specifically related to the research study: a) electrocardiogram, b) blood pressure, pulse, height, weight, and temperature measurements, c) phlebotomy and specimen processing and shipping, d) pulse oximetry
• Bachelor’s degree in Nursing or other related field
• Excellent interpersonal, communication, organizational skills, and ability to problem solve and multi-task
• Ability to perform common RN duties such as: drug administration, infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures

Clinical Research Clinical Associate Resume Examples & Samples

• Prior research experience required
• Experience with statistics and big data highly recommended
• Biology or health sciences background preferred
• Interest in authoring publications preferred
• Two year college degree and two years related work experience or a Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience

Technician, Acpru Clinical Research Resume Examples & Samples

• Communicates and interacts in a professional manner with AbbVie Clinical Pharmacology Research Unit (ACPRU) personnel, study projects, and other internal/external departments
• Maintains accurate and complete source data in PIMS and/or the source documents and communicates source discrepancies or issues, as appropriate
• Performs study-related protocol activities, i-e., ECGs, blood draws, meals, etc…as assigned
• Maintains safety and confidentiality of study subjects throughout the study and communicates safety related information in an appropriate manner
• Assists with the training of entry level Research Technicians and provides feedback of trainees progress on a regular basis
• Participates in quality and compliance improvement projects
• Understands and complies with SOPs, FDA regulations, basic GCP requirements and identifies potential risk of compliance deficiencies
• Maintains volunteer database with prompt and timely updates and informs the R&S Clinical Research Nurse of progress
• Performs phone interviews regarding the volunteers eligibility based on the inclusion/exclusion criteria and refers issues to the R&S Clinical Research Nurse as appropriate
• Performs pre-study R&S setup i-e. R&S calls, document preparation, laboratory set-up, label preparation, lab ordering, performance of QC checks, and inclusion/exclusion sign-off and obtains confirmation from the R&S Clinical Research Nurse as appropriate

VP, Clinical Research & Medical Affairs Resume Examples & Samples

• Interact with Cerus management to define and develop clinical strategies consistent with business objectives and regulatory requirements
• Direct activities related to phase 1-4 clinical trials (e.g., protocol development, design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, and study analysis and reporting)
• Provides clinical input into target product profile and commercial planning activities
• Ensure CRMA adherence to national and international regulations and standards (GCP, MDD, ICH)
• Lead interactions with Steering Committees and Data Monitoring Committees
• Oversight of adherence to protocols and regulatory requirements, assuring safety of study subjects
• Write medical monitoring plans. Review adverse events, monitor safety and prepare analysis and regulatory submission
• Participate in the review and editing of regulatory submissions and quality documentation
• Interact with Marketing, Product Development, Medical Science Liaisons, Hospital Implementation and Global Scientific Affairs for strategic positioning and support of clinical trials and needed medical data
• Interact with Regulatory Affairs for positioning regulatory strategy
• Cultivate and maintain key relationships with outside business partners, scientific and clinical advisors, and therapeutic thought-leaders
• Oversee operational activities and CRMA personnel including clinical research, drug safety and biostatistics
• Manage and participate in human resources/organizational development activities including; recruitment of key CRMA personnel, performance management, employee development and training
• Draft annual clinical budgets and ensure budgets and schedules are met
• Participate in scientific publications and presentations; and review of publications to insure consistency with corporate objectives
• Provide clinical trials result data in medical journals and present results at conferences and symposiums
• Ensure quality system compliance as it relates to area of responsibility
• MD degree: Prefer Board Certification (or Eligible) in related field (e.g., Hematology, Transfusion Medicine, Internal Medicine, Pediatrics and Infectious Diseases)
• Minimum of 10 years clinical trial experience; includes 5 years management background and 5 years clinical/drug/medical device development experience in the biotechnology or pharmaceutical industry
• Demonstrated significant, successful ability to conduct clinical development in an industry setting, including IND, NDA, PMA or BLA filing experience
• Thorough understanding of regulatory requirements
• Strong negotiation skills to influence policy making bodies both internally and externally
• Ability to integrate clinical expertise with Cerus business objectives; strong sense of Company with ability to translate corporate goals into project plan
• Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented
• Ability to effectively communicate (encompasses verbal, written, interpersonal, listening); ability to communicate across multiple disciplines successfully (internally and externally)
• Needs to be comfortable, and indeed thrive in a flexible, dynamically changing and challenging environment
• Willing and able to travel up to 30% of the time
• Supporting the development and execution of US product medical strategy, via the US Medical Plan, including launch support and lifecycle management, in collaboration with Product Team/Portfolio Governance and alignment with Global strategy
• Supporting definition of scientific evidence gaps, development of local evidence generation strategy in coordination with Global
• Supporting clinical trial conduct
• Participating in engagement of external key stakeholders (often in partnership with other functions)
• Supports Medical input into label and regulatory interactions, in alignment and with deep understanding of global strategy and program clinical trial data
• Supports implementation of Medical governance for respective product, which includes
• 2+ years of Clinical, Research or Medical Affairs experience
• Accredited fellowship in Rheumatology
• Board certified or board eligible
• Clinical research/medical affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
• Experience with clinical study management and conduct
• Familiarity with US health care compliance considerations
• Experience with opinion leader interactions
• Experience with integrated delivery networks, accountable care organizations, and payers
• Broad and formal leadership experience

Clinical Research Dev Lead, Early Development Resume Examples & Samples

• MD/DO with experience in vaccinology / immunology
• Minimum 3 years industry experience or
• 10 years experience working in a scientific or medical institution
• Knowledge and understanding of vaccines, clinical research, translational science, and biomedical research regulation, including ICH and GCP
• Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape
• Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum
• MD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology
• Able to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks
• Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making
• Needs to possess highly effective communication skills and be capable of presenting ideas and data clearly to various audiences
• License to practice medicine and board and/ or professional certification is an asset
• Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to)
• Retrieve, sort and collects data from hard copy and electronic database
• Manage data processing applications, maintain hard copy and electronic files and is accountable for accurate and timely processing of all research data
• Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft Power Point, and statistical software such as SPSS in order to analyze data and produce reports
• Perform a variety of duties concerned with the collection, analysis, evaluation and dissemination of DMH-related research
• Serve as an investigator on protocols related to human research
• Provide technical support for these studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
• Establish and maintain electronic records of current and past research, academic activities such as lectures and training courses, and publications, including original research, case reports, text books, letters to the editor, book chapters, etc
• Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design
• Maintain research packets for use by investigators in the DMH
• Contact study enrolled patients via telephone, email, or in person as needed for data collection for research protocols
• Alert investigators to Institutional Review Board (IRB) deadlines, by serving as liaison between the Clinical Investigation Department and the DMH
• Assist investigators with or independently create and prepare materials for initial reviews, continuing reviews, and terminations of research protocols as required by the IRB or IACUC
• Establish schedules to meet required protocol timeframes, facility availability, and investigator work schedules
• Receive individual assignments from Staff and Residents which involve specialized and/or short-term studies; identifies information sources, collects, researches and assembles background data; creates special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
• Function as the administrator for all research assistants and research coordinators, temporary or permanent, when working on DMH projects
• Provide oversight to DMH residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
• Provide other duties that are within the scope of work

Clinical Research Parasitologist Resume Examples & Samples

• Designs, implements and reports parasitology studies on ecto- and endo-parasites in both companion and food-producing animals
• Serves as investigator as in-house parasitology studies for development drug candidates and label extensions of approved products
• Ensures compliance with Good Clinical Practices (GCP) and occasionally Good Laboratory Practice (GLP)
• Supports external parasitology studies, as needed
• Maintains contact with the all stakeholders (project leader, RA, Quality Assurance (QA) etc. and keeps them informed of the study progress
• Implements and manages a parasitology laboratory, including rearing and maintaining colonies of ectoparasites and gastrointestinal nematodes
• Trains and manages laboratory technician(s)
• Defines objectives, budgets, resources, timelines associated with the parasitology laboratory
• Supports pre-development activities as required, including implementation of sensitivity assays, evaluation of formulations and dose characterization studies
• Supports biological activities related to parasitology
• Participates, as required, in meetings with management and/or regulatory agencies to present parasitology topics
• Develops and maintains a network of clinical parasitology and scientific contacts
• Minimum of (3) years of experience parasitology research, which may include graduate study in a relevant scientific field
• Familiarity with MS Office programs
• Familiarity with the principles of Good Clinical Practice and Good Laboratory Practice

Clinical Research Representative Resume Examples & Samples

• Maintains current and accurate protocol documentation and notifies appropriate individuals of pertinent protocol changes. Identifies and communicates important protocol and data management issues to appropriate sponsors
• Recruits participants for research studies. Determines participant eligibility based on study specific criteria. Verifies that patients have completed appropriate registration materials and maintains related records and information. Obtains and reviews relevant medical history with participants
• May serve as a backup, collecting and processing phlebotomy specimens for analysis using appropriate or specified equipment. Ensures proper labeling and obtains pertinent clinical and protocol information on request forms. Performs vital signs and EKG as appropriate
• Trains other Research Assistants in scheduling and data entry systems and in clinical procedures such as EKG, vital signs and phlebotomy
• Provide consultation, differential diagnosis, and treatment planning for all disorders defined by the Diagnostic and Statistical Manual for Mental Disorders to adults (including, but not limited to): organic mental disorders; psychotic disorders; schizophrenia; delusional disorders; mood disorders; anxiety disorders; somatoform disorders; psychoactive substance use disorders; sleep disorders; factitious disorders; impulse control disorders; psychological factors affecting physical condition; disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders; conditions not attributable to a mental disorder that are a focus of attention or treatment; sexual disorders; adjustment disorders; personality disorders; dissociative disorders; post-traumatic stress syndrome; etc
• Provides diagnostic and therapeutic procedures (including but not limited to): interviewing; major types of psychotherapy including: short term, long term, psychodynamic, family, marital, group, individual and behavioral therapy; community outreach (e.g., health promotion and command consultation); mental status examination; crisis intervention; case management; medical discharge planning; psychosocial history taking; psychological test administration and interpretation; etc
• Serve as an investigator on protocols related to human research. Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data
• Write and prepare research applications, conduct literature searches for background information, conduct research, collect and analyze data, perform statistical analyses, perform scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
• Manage data processing applications, maintain hard copy and electronic files and be accountable for accurate and timely processing of all research data
• Use advanced and varied functions of several software programs like Microsoft Excel, graphics programs such as Microsoft PowerPoint, and statistical software such as SPSS in order to analyze data and produce reports
• Provide technical support for research studies to include investigator training, procedural assistance, data collection, presentation preparation, scientific writing, and publication
• Assist investigators with protocol design, to include research questions, background, literature searches, experimental procedures and data sheet design. Maintain research packets for use by investigators
• Receive and complete individual assignments from Staff and Residents, which involve specialized and/or short-term studies; identify information sources; collect, research and assemble background data; create special study reports, which may also include other departments within the command or BUMED. These reports may require in-depth analysis
• Function as the administrator for all research assistants and research coordinators, temporary or permanent
• Provide oversight to Residents or Psychology Trainees in the conduct of research, data collection and data compilation. This oversight will ensure adherence to government and institutionally-mandated rules and regulations, the protection of human and animal subjects, and the maintenance of patient confidentiality
• Experience with Trauma Management Therapy similar to the therapy discussed in the following reference is preferred
• Beidel, D. C., Frueh, B. C., Uhde, T. W., Wong, N., & Mentrikoski, J. M. (2011). Multicomponent behavioral treatment for chronic combat-related posttraumatic stress disorder: A randomized controlled trial. Journal of Anxiety Disorders, 25(2), 224-31. doi:10.1016/j.janxdis.2010.09.006
• Knowledge of U.S. Navy; Naval Medical Center, Portsmouth; and/or Directorate of Mental Health policies and procedures is preferable, but not required
• Knowledge of the Directorate of Mental Health functions in order to comprehend the scope of care and interactions of this directorate is preferable, but not required
• Education: Graduation from an accredited school of nursing
• Experience: A minimum of 1 year of RN experience
• 1 year of RN experience in research and/or oncology
• Bachelor of Science in Nursing (BSN)

Associate Clinical Research Resume Examples & Samples

• Ensures validity of study by identifying/resolving
• A University degree is preferred or equivalent experience
• Three to six years of related work experience is required
• Strong verbal communication and interpersonal skills
• A mechanical aptitude and good organizational skills
• A keen interest in continuous learning
• Experience running cartridges and dealing with blood is preferred
• Science/Chemistry/Biochemistry and/or phlebotomy experience would be considered an asset
• Personal attributes: professionalism , adaptability, approachability, enthusiasm, excellent attention to detail, self-motivated, shows initiative and can work effectively as part of a team
• You must be a self-starter and have the ability to follow instructions and use good judgment. The individual must be flexible and be able to work in a fast paced environment with changing priorities
• This position requires someone who can work Monday through Friday from 8:00 a.m. to 5:00 p.m

Clinical Research Coordinator, Certified Resume Examples & Samples

• Recognizes, tracks and reports adverse events and protocol deviations
• Represents the research program at meetings, national and international research consortia
• Prepares, submits and maintains IRB, FDA, NCI, NIH, NSF and/or other regulatory documents and research correspondence
• Coordinates with referring physicians to provide information regarding available research projects and to maintain a strong referral basis
• Note: The ideal candidate will reside within the region
• Minimum of 1 year monitoring experience with a pharmaceutical company and/or CRO
• Minimum of 1 year experience of monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc in the U.S.A
• Proficient in the use of core trial management systems
• If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas to CRA for improving site recruitment plan in line with project needs to enhance predictability. Assist CRA in tracking subject site recruitment progress
• Under close supervision, evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase
• Under close supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
• Convey features and opportunities of study to site
• Collaborate and liaise with study team members for project execution support as appropriate
• Good written and verbal communication skills including good command of English language

Specialist, Clinical Research Resume Examples & Samples

• Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements
• Edit/amend informed consent documents
• Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery
• Provide leadership and oversight for clinical study operations world-wide
• Establish mechanisms to track and report 3M’s global clinical research activities and impact
• Ensure that OUS clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
• Collaborate with division clinical managers to develop clinical studies to support division’s priorities and businesses
• Bachelor's degree or higher from an accredited institution
• Minimum of ten (10) years of pharmaceutical, medical device and/or academic health care experience
• Minimum of ten (10) years pre-clinical and/or clinical research experience
• Master’s degree or higher in a Science discipline from an accredited institution
• Minimum of five (5) years of medical device experience
• Experience with new product development programs
• Proven process improvement experience such as Six Sigma
• Strong communication skills and a demonstrated ability to work collaboratively with multiple functions and organizations
• 3M experience working across multiple disciplines, businesses and/or departments (applies to internal applicants only)
• Manage and develop a team of Clinical Research Professionals
• Collaborate with the division and Clinical Managers to develop clinical studies to support division’s priorities and businesses
• Establish mechanisms to track and report clinical research activities and impact
• Ensure that clinical teams and their studies meet HCBG standards, global/local guidelines, laws and regulations
• Propagate necessary policies and procedures to ensure compliance
• Provide and facilitate clinical planning in support of business initiatives
• Bachelor’s degree or higher from an accredited institution
• Minimum of five (5) years combined experience working in a clinical research and/or technical environment
• Bachelor’s degree or higher in Science, another health care discipline (e.g. MD/DO, RN, PharmD, MPH) or related discipline from an accredited institution
• Minimum of five (5) years clinical trial management experience
• Minimum of two (2) years supervisory experience
• Certification, or willingness to obtain Association of Clinical Research Professionals (ACRP) Certified Clinical Research Accreditation (CCRA®)
• Experience working with health economics studies
• Demonstrated understanding of Good Clinical Practices (GCPs) and clinical trial regulations
• Previous experience leading cross functional teams
• Ability to influence across the Health Care Business
• Unlike some CRA roles you will not be pushed to satisfy
• All aspects of site management as prescribed in the project
• Negotiation of study budgets with potential investigators and
• Excellent verbal and written communication skills in English and Spanish
• Prior experience with patients or research subjects is desired. Preference given to applicants with previous experience, particularly clinical research experience, with older adults who may have neurological impairment (e.g., Parkinson’s disease) or cognitive impairment (e.g., Alzheimer’s disease)
• Ability to communicate clearly and empathetically with research participants and their families
• Strong interpersonal skills, including the ability to work easily with research participants and research team members
• Strong general computer skills and ability to quickly learn and master computer programs
• Proficiency with Microsoft Office and Excel

Clinical Research Protocol Analyst Resume Examples & Samples

• Bachelor’s degree in relevant field such as biology, biomedical engineering, psychology, nursing, or public health
• Advanced degree (PhD, PharmD, MPH) and/or clinical background (nursing or MD) preferred
• Minimum 4 years experience in clinical research and/or patient recruitment
• Experience interacting directly with patients in a research setting is a plus
• Ability to analyze with strong attention to details
• Persuasive writing skills and the ability to simplify complex medical concepts
• Strong organizational skills and ability to perform multiple tasks
• Ability to work independently, function effectively as a member of a team and adhere to strict deadlines
• Ability and willingness to work collaboratively across multiple teams (Sales, Analytics, Proposals, Project management, IT, Media, etc.)
• Strong working knowledge of (Word, Excel, PowerPoint) in a PC environment
• Demonstrated comprehensive understanding of clinical research patient recruitment across multiple therapeutic areas

Assistant Site Clinical Research Associate Resume Examples & Samples

• Supports the (Associate)/(Senior) ClinicalOperations Manager, Site Clinical Research Associates and any other clinicalresearch personnel involved, in the in-house organization, management and execution of projects to ensure the clinical trials are conducted, recorded and reported in accordance with the protocol, Standard Operation Procedures and applicable global, local and regulatory requirements and companyobjectives
• The AssistantClinical Research Associate is key participant in the study startup activities and site openingactivities as well as study conduct and site closure tasks
• May managethe activities of clinical Investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This positionmay assume independent site management responsibility in accordance with experience and performance
• Supports and/or conducts (accompanied) site qualification, initiation, interim monitoring and study closeout visitsfor Phase 1-4 studies in accordance with local regulations, Good Clinical Practices(GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and businessprocesses, if applicable
• Conducts assigned clinical site activities and/or supports the (Sr.) SCRA in those according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to
• Manages the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas, with appropriate supervision
• Manages the overallactivities of site personnel and motivate/influence them to meet study objectives, with appropriate supervision
• Ensures qualityof data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
• Ensures safety and protectionof study subjectsaccording to the monitoring plan, AbbVie SOPs, ICH Guidelines, and federal regulations
• Appropriately escalates serious or outstanding issues to (Sr)/ (Associate) Clinical Operations Manager or the appropriate project team member(s)as defined in the study monitoring plan
• Facilitates Quality Assurance Audit processes as indicated. Ensures regulatory inspection readiness at assigned clinical sites.Reports monitoring activities and study site conductaccurately and completely. Prepare and submit written reports,both monitoring and administrative, with appropriate supervision. Keep management informedof study progress through periodic updates
• Supports SCRAs with Clinical Trial Application submissions, including relevant informed consent local changes and translations into local language as required
• Assists to conserve costs of departmental operation and control of travel expenses, with guidance from (Sr) Clinical Operations Manager
• Assists in study budget preparation and clinical study agreement execution, including ensuring necessary payments are made according to executed agreements
• Negotiates investigator/ hospital agreements with stakeholders. Maintainsand completes own expensereports as per local and applicable guidelines
• Participates in departmental meetings
• Supports new and innovative processes and technologies to increase the quality, productivity, and efficiency of Clinical Operations and conserve overall departmental operating costs
• Gains knowledge and expertise acrossmulti-therapeutic areas throughclinical and scientificliterature review, ongoingawareness of industry practices and participation in professional activities
• Undergoes and maintainstraining as requiredby Global ClinicalOperations and otherrelevant company procedures, to ensure adherenceto federal regulations, Good Clinical Practices (GCPs),ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes
• Appropriate life-science or healthcare-related qualification or experienceor equivalent work experience
• Appropriate tertiary qualification, health related(e.g., Medical, Scientific, Nursing) preferred
• One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company is preferred. Current knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trialsis preferred
• Knowledge of conducting industry-sponsored clinical research (e.g. Clinical study coordinator/ data manager, clinical trial assistant (or equivalent), regulatory document specialist) is preferred. Knowledge related to ICH/GCP Guidelinesand applicable local regulations is preferred
• Good planningand organizational skillsand the ability to work effectively and efficiently in a dynamicenvironment with competingprojects and deadlines
• Good written and verbal communication skills.Written and verbal fluency in English and local language (if not English).Good observational skills,analytical and conceptual capabilities. Attention to detailand strong interpersonal skills
• Ability to work, understand and follow work processes within the assigned function

Data Analyst, Clinical Research Resume Examples & Samples

• Performs all data management activities for assigned studies, as appropriate
• Protocol and Statistical Analysis Plan (SAP) review and input
• Case Report Form (CRF) development and maintenance
• Edit Check specifications development and maintenance
• Data Management Plan development and maintenance
• Data Quality Checks and discrepancy management
• Analyzes data, identifies trends; prepares data tables for reports
• Database setup testing and Edit Check programming testing
• External data handling
• Device reconciliation and tracking for investigational product
• Participate in Post Market Surveillance reporting as appropriate
• Additional study specific activities
• Ensures that all data management activities for assigned studies are completed on time and with high quality or escalates as appropriate
• Communicates well with peers, study teams and management as appropriate to support studies and goals
• Participates in efforts to improve Data Management processes, as needed/assigned
• Represents the Data Management group at study team meetings
• May represent the Data Management group on cross-functional task forces
• May train and mentor other Clinical Data Associates (CDAs) and Clinical Data Coordinators (CDCs) on certain tasks
• Applies best practices and established standards
• Serves as a liaison between the study team and clinical data operations
• Is a Subject Matter Expert (SME) in one or more areas within Data Management
• Has a general understanding of the clinical trial process and regulations that apply, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies
• Communicates and collaborates with all levels of employees, customers, contractors, and vendors
• Provides input to departmental Standard Operating Procedures (SOPs), Departmental Work Instruction (DWIs), and guidelines
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
• Complies with U.S. Food and Drug Administration (FDA) regulations, International Conference on Harmonisation (ICH), ISO 14155, other regulatory requirements, applicable company policies, operating procedures and processes
• Performs other related duties and responsibilities, on occasion, as assigned
• Typically a minimum of four plus years’ experience working in a clinical research environment, experience to include a good understanding of clinical data management processes
• Good organizational and project management skills, as well as attention to detail
• Highly skilled with MS Office, especially Excel, Word, Publisher and Powerpoint
• Strong ability to work with Clinical Data Management Systems
• Understands databases; good technical skills in querying and analyzing data (SQL, Oracle, SAS or equivalent)
• Certified Clinical Data Manager (CCDM) preferred
• Ability to work in a highly matrixed and geographically diverse business environment
• Ability to leverage and/or engage others to accomplish projects
• Strong verbal and written
• Multitasks, prioritizes and meets deadlines in timely manner
• Ability to travel approximately 10%
• Ability to maintain regular and predictable attendance
• Bachelor's Degree in Computer Science, Health Sciences, Informatics, related field, or equivalent

MCI Clinical Research Coordinator Resume Examples & Samples

• In lieu of degree, 7 years of oncology research or 9 years of research experience required
• CITI Certification required
• Must have broad experience in clinical trials
• Clinical Research Coordinator Certification preferred
• Computer literacy in Microsoft Office (MS Access, MS Word, and MS Excel) and Electronic Capture Platforms
• Ability to manage multiple projects/protocols systematically and strong proofreading skills
• Excellent interpersonal, collaborative, and team-building skills are required
• Must be able to work in high-stress, high volume area and multi-task to ensure enrollment of patients in research protocols according to regulatory requirements

Clinical Research Coop Resume Examples & Samples

• The general task and duties for this job is to collaborate with management, scientists, engineers, technicians, and test participants in order to design, execute, and complete projects
• Work individually and in a team environment, includes cross-functional teams
• Apply problem-solving skills to resolve scientific issues
• Develop testing protocols; administer testing, analyzing and reporting the data
• Ability to take initiative, think and work independently, problem-solve, work in teams and multitask; a solution orientated professional
• This position actively participates in the execution and collection of research data of clinical investigations on Edgewell Personal Care products
• The primary locations of this research will be at 50 & 60 Commerce Park, both in Milford CT
• This position will help in designing, executing, analyzing and reporting the results of clinical investigations on Edgewell Personal Care products
• This position executes clinical investigations of personal products, which may include direct contact with study participants to obtain measurements of skin properties
• Facilitates clinical studies execution including preparing study documentation, supplies, labeling and dispensing test product, recruiting/scheduling/reporting panelist participation, and other study related responsibilities as needed
• Supports other functions of The Institute of Evaluation Sciences or other Edgewell facilities as necessary
• Junior or Senior studying Biology or Psychology with effective verbal and written communication skills
• Ability to conduct statistical data analysis and its interpretation
• Past work experience in industry
• Experience with automated data collection systems
• Owns a valid driver’s license

Clinical Research Financial Manager Resume Examples & Samples

• Provides collaborative leadership and management oversight and coordination of special research projects for the NIAID, Division of Clinical Research (DCR), Office of Planning and Operations Support (OPOS)
• Performs a significant level of project/program management activities including utilizing project/program management tools and techniques to organize, plan, execute, report, and evaluate budget objectives
• Serves as the primary interface for the budget management and planning of clinical research projects and other associated activities
• Provides collaborative financial leadership and coordination of all budget components
• Develops, maintains and tracks detailed site management budgets identifying applicable clinical research activities, tests, and other associated activities (e.g., subcontracts) to be performed during the conduct of a clinical research protocol
• Ensures coordination and dissemination of information that would financially impact the clinical research projects by facilitating and maintaining strong communication channels among the many entities participating such as: NIH teams, investigators/colleagues, Leidos Biomed staff, subcontractors, etc
• Works independently to assess complex financial requirements
• Communicates with the CMRP Director, senior management, program staff and NIAID DCR project officials to provide consistent and accurate information
• Participates in the financial execution of projects and provides technical guidance in the development of operational, technical and budget processes, templates, procedure manuals, and other documents
• Prepares, monitors and analyzes financial forecasting, cost proposals, and reports
• Monitors budget progress against complex project plans/key deliverables and provides monthly expense analyses
• Manages budget risks by proactively anticipating issues and develops contingency plans and solutions
• Conducts financial meetings and assists in the development of meeting agendas and summary reports as requested
• Supervises staff
• Possession of a Master’s degree from an accredited college/university in a field related to biomedical research/clinical trials/health or six (6) years related experience in lieu of degree
• A minimum of ten (10) years of progressively responsible, relevant experience in clinical research, including a minimum of six (6) years directly managing financial activities for protocols, site management and/or clinical research activities
• In-depth knowledge of study design, clinical and bio-specimen terms used in research studies and scientific and medical concepts and terminology
• Comprehensive knowledge of accounting theories, principles, procedures and methods, report analysis, contracting principles, provisions, reporting requirements and cash flow requirements
• Excellent research and investigative skills with a high degree of accuracy and attention to detail
• Extensive budgetary and strategic planning experience as it relates to clinical research
• Ability to review complex documents independently and/or in collaboration with various stakeholders, and determine sufficiency of financial documentation
• Experience in leading and developing team members
• Must be detail-oriented, creative and flexible
• Advance proficiency in Microsoft Excel, Word, and PowerPoint
• Clinical Research or Project Management Professional with infectious disease experience
• Experience in human subjects protection and clinical research activities
• Familiarity with Federal Acquisition Regulations (FARs)
• Highly professional demeanor and positive attitude
• Bachelor’s degree in related field required
• 1 to 3 years of clinical research experience involving human subjects, IRB methodology, and working with a clinical research team
• Must be able to multitask and prioritize effectively
• Ability to work as part of a team or individually while meeting deadlines in a multitasking environment
• Comfort with and proficiency in software applications used to support research processes (eResearch, etc)
• Previous experience with MiChart, RedCap
• Background in a medical field and knowledge of medical terminology
• Flexible schedule is required, as some weekend (day) coverage may occasionally be required

Clinical Research Associate, Senior Resume Examples & Samples

• Responsible for overall study process and adherence to clinical trial procedures by keeping oversight, identifying possible problems / risks, creating mitigation plans, taking actions or corrective actions using timely communication
• Contribute to protocol development and study related documents such as informed consent related to monitoring activities
• Develop the monitoring plan for clinical studies
• Ensure compliance to ICH/GCP/local regulations
• Confirm and track that all key site personnel have project specific training
• Responsible for study status reports, essential documents, and accurate study files
• Assist with resolution of investigational site/data queries
• Liaise with project team members regarding study site issues
• Travel to study sites for meetings and monitoring visits upon request (ca. 40% travel of which 10% international)
• Experience as a clinical research associate minimum of three years, five years preferred
• Bachelor’s degree, in biological sciences or healthcare
• Excellent interpersonal and organizational skills
• A pro-active, committed and motivated attitude
• Ability to work very accurate and thorough
• Ability to work well in a team environment but also independently without significant oversight
• Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines

Clinical Research Associate Respiratory Therapy Resume Examples & Samples

• Work closely with R&D Engineers and Product Managers to provide in-depth clinical respiratory therapy knowledge in support of product development
• Respond to questions from engineering regarding metrics, etc. pertaining to respiratory therapy guidelines
• Perform research as needed to provide applicable information
• Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing
• Identify issues that need resolution to ensure safety and effectiveness of the products
• Participate in cross-functional meetings to provide clinical perspective and knowledge
• Knowledge of how to, or a willingness to learn to, write protocols, reports, and other forms of research projects for various studies that Clinical Affairs is engaged in
• Perform medical diagnostic tests such as electrocardiograms, blood pressure checks, glucose measurements, etc
• Collect and process blood and urine samples per protocol requirements
• Professionally interact with subjects, visitors, staff, and other healthcare professionals
• Maintain nurse’s station inventory
• Sanitize and stock treatment rooms and subject bedrooms
• Dispose of and replace biohazard waste in lab and exam rooms per OSHA requirements
• Perform administrative tasks as needed
• Troubleshoot any study issues
• Order and prepare lunch for subjects as needed
• Other duties and responsibilities as assigned or directed
• Ability to communicate in a clear and professional manner
• Adhere to Good Clinical Practices (GCP)
• Attention to detail and accuracy in completing tasks
• EMT and BLS certification required
• Paramedic and ACLS certification required
• Registered Nurse degree required
• Serve as a central contact for communications/correspondence between the Generic Product Development, Biopharmaceutics Group, and CROs and other vendors
• Review the study protocols and if needed help to design data collection from known case report forms (CFRs)
• Identify and assess the suitability of clinical and bioanalytical facilities for bioequivalence studies. Conducting general GCP and GLP audits
• Maintain study schedules, request proposals/contracts from CROs, compare competiveness and work quality of the CROs, maintain study budgets, initiates CDAs with different vendors, process vendor contracts and ensures payments are sent on time to vendors
• Monitor trials throughout their duration, which involves visiting the trial sites on a regular basis
• Verify that data entered onto the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Write visit and audit reports
• Analyze and interpret scientific data using Phoenix WinNonlin and other databases
• Generate and track drug shipments and ensure timely delivery of final clinical and bioanalytical reports for regulatory submissions
• Ensure all unused trial supplies are accounted for and stored properly
• Perform duties such as bulk copying and faxing, and filing of correspondence, lab reports, Clinical Monitoring Reports, and other study documents
• Assist coordination of study logistics, documents, drug shipments, enrollment and safety 5%
• Collect regulatory documents required for study initiation
• Maintain central study files in a state of audit-readiness
• Maintain reference products inventory list and order products when needed. Maintain reference products inventory list and order products when needed
• Communicate regularly with Generic Products Development teams: provide information, track study randomization codes, reports, may follow up on problems identified during the study
• Perform all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, appropriate industry and Good Clinical Practices, Good Laboratory Practice and Applicable Regulatory Guidance standards
• 8 years of experience with medical terminology, GCP, GLP and Pharmaceutical Industry Regulatory guidelines is required
• 5+ years of demonstrated proficient with MS Office (Word, Excel, Access, and PowerPoint), email, internet, required
• 2+ year of experience using computerized systems i.e., Phoenix WinNonlin, SAS, and other databases required
• 2+ years of experience analyzing and interpreting scientific data and skilled use of computerized systems and databases required
• 8 years work experience in clinical and bioanalytical science environment required
• BA/BS in Psychology, Public Health, Social Work or related social science field
• Experience with social science research, ideally with children
• Knowledge of University administrative systems

Clinical Research Coordinator Trauma & Critical Care Resume Examples & Samples

• Ethical and participant safety considerations. Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research. Train junior staff in the ethical conduct of research. May help in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations. May develop, or assist with the development of, documents related to safety and security
• Data management and informatics. Use and train others in Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations. Score tests, enter data, and complete Case Report Forms accurately and according to protocol. Assist with the development of, or develop, data collection documents and instruments. Detect issues related to data capture, collection or management; suggest solutions. Investigate incomplete, inaccurate, or missing data/documents to ensure accuracy and completeness of data; follow and develop, or assist with development of, SOPs for data quality assurance. Adhere to processes and run queries, summaries, and reports to monitor the quality of data. May develop QA processes and oversee the creation and use of queries, summaries, and reports for quality assurance purposes. May be responsible for recognizing trends related to data quality and escalating as appropriate. Use required processes, policies, and systems to ensure data security and data provenance. Recognize and report vulnerabilities related to security of physical and electronic data; suggest and implement solutions to vulnerabilities related to security of data and data provenance. Map protocol data flow. Predict areas of vulnerability for a protocol#s data flow plan. Determine areas where data provenance may be compromised and develop solutions
• Scientific concepts and research design. Understand and train others in the basic concepts of study design. Independently conduct literature reviews. Assist with the development of, or develop, proposals or protocols; identify shortcomings of proposals and protocols. Identify various stakeholders (statistical, operational, etc.) to ensure adequate design, implementation, and testing of study aims. May determine operational/statistical elements needed for conduct of clinical and translational studies
• Leadership and professionalism. Assist research colleagues in identifying efficiencies and improving process. Successfully take part in or lead a committee or task force. Actively seek out continuing education opportunities for self and study team members. Participate in or lead scientific presentations and publications. Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including other CRCs. Employ escalation and performance plans as needed. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research; summarize and clarify for study teams. May be responsible for identifying potential problems and risks to the participants,study, and institution
• Study and site management. Participate in sponsor-required training. Obtain information for or coordinate operational plans for multiple research studies. Develop protocol-specific systems and documents including process flows, training manuals, SOPs, and CRFs. Ensure participant care expenses have appropriate financial routing. Monitor financial study milestones and report appropriately. Coordinate with financial teams, PRMO, etc. Assist with study budgets. Prepare for, take part in, and potentially lead site initiation, monitoring, closeout visits, and document storage activities. Collect information to determine feasibility, recruitment and retention strategies. Maintain compliance with institutional requirements and policies. Oversee maintenance of Delegation of Authority Logs and training of KP on study specific duties
• Communication and team science. Prepare for and lead team meetings. Take an active role in including others in decision-making, and escalate issues appropriately. Communicate with sponsors, subcontractors, or vendors. Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research

Clinical Research Associate, Temporary Resume Examples & Samples

• Ensure the conduct of all clinical studies is in accordance with Good Clinical Practices, International Harmonization Guideline, and appropriate Standard Operating Procedures (SOP)
• Actively participate in the implementation and execution of clinical trial activities from study planning through closure
• May perform site qualification, initiation, monitoring, and/or close out site visits
• Develop and maintain tracking tools to support management of clinical studies
• Participate in site budget negotiations
• Assist in developing and managing study timelines
• Plan and participate in Investigator meetings and CRA trainings
• Assure regulatory compliance of investigational sites with SOP’s and FDA and ICH guidelines
• Minimum of 3+ years of experience in the pharmaceutical / biotechnology industry performing as a Clinical Research Associate with a combination of experience in in-house study management from study start-up to database lock, as well as, clinical site monitoring experience
• Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc
• Experience in protocol development/writing is preferred
• Experience in international or global clinical trials is preferred
• Possess good understanding of ICH guidelines, Good Clinical Practices (GCP), PhRMA code, FDA CFR, clinical research ethics, HIPAA and patient privacy laws, EU directive, and other relevant, local regulatory requirements
• Good knowledge of concepts of clinical research and drug development
• Ability to travel up to 25% travel including ground and air required
• Organic mental disorders
• Psychotic disorders
• Schizophrenia
• Delusional disorders
• Mood disorders
• Anxiety disorders
• Somatoform disorders
• Psychoactive substance use disorders
• Sleep disorders
• Factitious disorders
• Impulse control disorders
• Psychological factors affecting physical condition
• Disorders usually first evident in infancy, childhood, or adolescence that manifest in an adult patient such as, eating disorders and gender-identity disorders
• Conditions not attributable to a mental disorder that are a focus of attention or treatment
• Sexual disorders
• Adjustment disorders
• Personality disorders
• Dissociative disorders
• Post-traumatic stress syndrome
• Interviewing
• Community outreach (e.g., health promotion and command consultation)
• Mental status examination
• Crisis intervention
• Case management
• Psychological test administration and interpretation
• Responsible for the conduct of research, the collection, accuracy, and analysis of research data, and reporting of said data in the DMH
• Write and prepare research applications, conducts literature searches for background information, conducts research, collects and analyzes data, performs statistical analyses, performs scientific writing and manuscript preparation, and submit completed manuscripts to academic journals or other sources as appropriate
• Possess a doctoral degree in clinical or counseling psychology
• Possess a valid, unrestricted license or certification to practice as a psychologist in any one of the 50 States, the District of Columbia, the Commonwealth or Puerto Rico, Guam or the U.S. Virgin Islands
• Experience with Trauma Management Therapy similar to the therapy discussed in the following reference preferred
• Complete MTF provided human subject protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date
• Knowledge of Federal regulations regarding the ethical conduct of research on humans
• Knowledge of the data collection techniques to identify and analyze problems, apply solutions, identify trends, and prepare charts and graphs utilizing available software programs such as Microsoft Office Suite
• Knowledge of Navy and Naval Medical Center Portsmouth and Directorate of Mental Health policies and procedures is preferable, but not required
• Skill in scientific writing and ability to use literature search databases in order to prepare research proposals, applications, presentation preparation, and manuscripts evidenced by publication in peer-reviewed journals, completed thesis/dissertation work (or equivalent), or endorsement of strong formal writing skill by previous employers or academic advisors
• Skill in using advanced and varied functions of several software programs such as Microsoft Excel, graphics programs such as Microsoft Power Point, and statistical software such as SPSS in order to organize and analyze data and produce reports
• Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, often changing conditions and research workload
• US citizenship and background investigations are required for this position

Clinical Research Evaluation Supervisor Resume Examples & Samples

• Manage, coordinate and execute clinical testing of sexually transmitted infections, blood borne infections and transfusion transmissible infections in support of clinical laboratory mission and research studies
• Oversight of US FDA Pre-Market Clinical Trials and other IRB approved clinical trials and non-clinical studies
• Support IRB submissions
• Support development of Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)
• Provide support for internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits
• Serve as point of contact for manufacturer and sponsor study coordinators
• Provide regular project updates to Principal Investigators
• 5 years of related experience including oversight of clinical trials

Clinical Research Data Manager Resume Examples & Samples

• Work closely with the scientific team to determine deliverables and study expectations
• Coordinate with our team of data analysts to establish all aspects of data collection, data transfers, data cleaning and reporting
• Contribute to cross-functional collaboration, decision-making and goal-setting

Oncore Ctms Clinical Research Calendar Builder Resume Examples & Samples

• Build and configure electronic study calendars with budget details for clinical trial data capture in accordance with the terms of the protocol
• Update OnCore protocol information as amendments occur to the protocol calendar/ budget
• Develop prioritization schema to aid in workload management for calendar and budget build tasks
• Provide input to and implement processes to ensure calendar and budget build reflect accurate trial information
• Perform system testing as directed and quality control of application functionality during application upgrades
• Assist coverage analysts, budget specialists and cancer center employees who encounter technical issues problems or have questions relating to OnCore
• Collaborate with direct supervisor, finance team, clinical research team, project manager, health system representatives, consultants and vendors to ensure overall completion of goals, schedules, and deadlines
• Stay up to date on all new and evolving institutional changes as they relate to policy, pricing, budgeting, etc. for clinical trial data captured in OnCore
• Provide ad hoc reporting to OnCore, Clinical Trials Office and Cancer Center leadership, as necessary
• Assist the OnCore team in developing learning tools as they relate to calendar/ budget building tasks
• Act as a resource to other calendar/ budget builders utilizing OnCore
• Knowledge of cancer research, the oncology field, or related experience

Associate Specialist, Clinical Research Resume Examples & Samples

• Assist in the preparation of study start up activities. Collaborate with monitoring team to coordinate on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as necessary to ensure study requirements are being fulfilled
• Identify and investigate discrepancies in documentation by applying clinical protocol knowledge and develop processes to minimize possibility of recurrence
• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and FDA audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
• Assist in the preparation of relevant portions of regulatory submissions for local and government regulatory bodies
• Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas
• Site management experience
• Site pre-qualification visits through close out visit experience
• Substantial computer literacy
• Understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting is preferred
• Able to apply appropriate clinical research SOPs, ISO guidelines, ICH/GCP guidelines, and FDA guidelines, as needed

Clinical Research Associate Finland Resume Examples & Samples

• Experience as a CRA in clinical development phases II-IV
• Capability to work in a team

Manager, Clinical Research Services Resume Examples & Samples

• Exceptional written and oral communication skills, to include presentation and report writing skills
• Demonstrated interpersonal skills, along with the ability to interact effectively with a diverse constituent population
• Demonstrated organizational and prioritization skills, along with the ability to meet deadline and focus on the completion of tasks
• Ability to generate and implement successful approaches to addressing research study related issues

Clinical Research Associate Apprenticeship Resume Examples & Samples

• Completes various training and related instruction and maintains detailed documentation of training completion
• Coordinates, oversees and completes administrative functions on assigned trials including, but not limited to, reviewing and transmitting regulatory documents, processing documents sent to file, QC and reconciling project reports, performing mass mailings and faxes, managing and distributing paper study supplies to sites
• Performs PPD investigator file reviews and logs findings in CTMS
• Maintains assigned data points within CTMS according to the established conventions within specified times
• Remotely reviews EDC (with or without source verification, depending on local practice and regulations) and drug accountability log. Performs source data verification from web-based sources where possible, and in compliance with local laws
• Writes, follows and resolves clinical queries and issues
• Evaluates, conducts and documents site management contacts according to the monitoring plan and conducts remote study-level training as needed to improve site performance and study compliance
• Evaluates PI oversight (e.g., protocol adherence), subject safety and study processes in order to assess site’s ability to conduct study
• Reviews and appropriately escalates site key risk/performance/quality indicators (SRAP, KRI, KPI, KQI [e.g., early termination and screen-fail rates, average number of open findings, etc.]) , ad-hoc clinical listings review, tracks and trends violations and deviations, ensures visits occurred per the MP, site status, enrollment, CRF status and SAE follow up
• Provides trial status tracking and progress update reports to CTM as required and ensures study systems are updated per agreed study conventions (e.g., CTMS)
• Liaises with CRA to promptly collect documents, review data points, findings from EDC and file reviews, etc
• Previous experience in a medical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care or experience in a health sciences field with formal training in medical terminology and anatomy may be considered
• Prefer individuals with leadership experience and training, such as Lean Six Sigma or equivalent
• Proven success in deadline driven environment a plus
• Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software

Advanced Practice Provider Head & Neck Medicine Clinical Research Resume Examples & Samples

• Capable of anticipating and balancing the needs to multiple stakeholders
• Resourceful, securing and deploying resources effectively and efficiently
• An effective communicator
• Openly relatable and comfortable with diverse groups of people
• Adaptable in approach and demeanor in real time to match the shifting demands of different situations
• Current New York State (NYS) RN and NP licenses/registrations
• Master’s degree in nursing, prescriptive privileges (or eligibility)
• 3+ years of related clinical experience
• Related National NP certification
• BLS certification
• Graduate from an accredited PA program
• NCCPA certification
• Active NYS license or be qualified for state licensure
• A minimum of 2 years of related experience as a PA is preferred

Lead Assistant Clinical Research Coordinator Resume Examples & Samples

• Strong clerical, interpersonal, and organizational skills
• Ability to exercise judgment and employ basic reasoning skills
• Clinical research experience

Intern Clinical Research Resume Examples & Samples

• Shadows and learns functions and or projects under the close supervision of a department employee
• Assignments are assigned to enhance and build upon the academic experience and the Intern is the primary beneficiary of this job. This job is designed to offer a professional work environment experience, two-way communication tactics, and exposure to the Quintiles organizational structure
• Assignments will reflect the work being accomplished within the business department and may include working on independent projects or as a member of a project team
• Performs other duties /learning activities as directed
• Appropriate verbal and written communication skills to function within a professional work environment
• Working knowledge of MS –Office suite of applications
• Pursuing BS/BA or a community college /vocational certification course
• Prefer junior or senior (i.e. in the last 1 or 2 years of the program), but will consider other class levels, as appropriate. Regional/country variations may apply
• Graduate of an accredited/approved school of Nursing
• Licensed as a Registered Nurse in the State of Alaska at time of hire
• Demonstrated ability to work as a team
• Bachelor’s Degree in Nursing (BSN) preferred
• Certification within area of expertise or practice preferred (OCN, CCRP)
• Two years of oncology nursing experience preferred

Bft-mgh Neurology Department Seeking Clinical Research Coordinator Resume Examples & Samples

• Recruit and schedule study participants
• Coordinate scheduling with other research coordinators and investigators
• Maintain documentation of recruitment activities
• Enter data into an electronic data capture system
• Monitor and reports adverse events as required by study protocol and institutional/federal regulations
• Resolve data discrepancies as requested by Sponsors

Emergency Medicine Clinical Research Coordinator Resume Examples & Samples

• Able to work as independently and as a team player
• Very good communication skills
• Ability to juggle multiple tasks, people and schedules
• Ability to demonstrate respect and professionalism for subjects' rights and individual needs
• Comfort with computers, specifically the Windows operating system, is essential
• Comfortable searching the Internet, as well as performing literature searches using Medline
• Proficiency in Microsoft Office, as well as the ability to learn how to use new software
• Staff member will be trained in phlebotomy and collection of vital signs

Clinical Research / RN Coordinator Resume Examples & Samples

• Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research
• Clinical competence in application of professional nursing theory, practice, and skills for the care of pediatric and adult patients
• Complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and integrity training within one month from start date

Clinical Research Coverage & Budget Analyst Resume Examples & Samples

• Comprehensive knowledge of medical terminology, pharmacology, disease processes, surgical and medical procedures
• Minimum of 3 years experience in a research setting, preferably in billing, coverage determinations and budgeting and/or understanding of research billing regulations
• Demonstrated understanding of ICD-9, ICD-10, CPT-4, HCPSC, coding protocols and CMS regulations
• Knowledge of clinical trial federal, state and local regulations preferred
• Experience with EPIC preferred
• Must have strong MSOffice computer skills, and ability to conduct Internet searches
• Strong project management, analytical, organizational, and problem solving skills
• Demonstrated ability to work on deadlines, set priorities and juggle multiple projects without compromising quality

Director, Global Clinical Research Resume Examples & Samples

• Manage and enhance a global portfolio of performance and especially clinical outcomes studies, and conduct such studies as appropriate, with an emphasis on microbiology and biomarkers
• Coordinate global performance and clinical outcomes projects
• Masters or higher in in a relevant field
• 4 years of relevant experience in the independent scientific and administrative conduct of clinical research studies
• Familiarity with a wide range of a empirical research techniques and basic statistical methods
• Additional languages, particularly Spanish, are a plus
• Adaptable and flexible to adjust to changing demands, timelines and deliverables
• Ability to exercise independent judgment, prioritize and take action as needed to drive own and other’s research to conclusion and publication
• Appropriate computer skills
• Strong team orientation to work with peers, Key Opinion Leaders, investigators, funders, and other players important to the success of the program and company

Head & Neck Clinical Research Liasion Resume Examples & Samples

• Theoretical knowledge and/or Bachelor’s Degree in a social science or basic science such as Biology, Microbiology or a related field and/or relevant related work experience
• Strong experience in research protocol start-up procedures, including study feasibility, study activation and IRB processes and qualification procedures
• Advanced knowledge of investigational protocol data management, query resolution, protocol design and protocol implementation
• Strong experience in clinical trials budget negotiations, including development, preparation and monitoring of clinical trials budgets, to reach agreement on payment, deliverables, and other issues to ensure the smooth and efficient execution of contractual obligations
• Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions
• Experience in providing work direction and assisting supervisor in maintaining an efficient medical research team
• Demonstrated knowledge of medical billing and collections guidelines and procedures. Experience in analyzing protocols to assist in determining standard of care versus research-related cost, and in monitoring financial activity on research accounts to verify accuracy of charges to the study account
• Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet
• Possess a Clinical Research Coordinator Certificate or Master’s Degree

Clinical Research Associate, / Senior Cra-uk Resume Examples & Samples

• General Medicine (Infectious Diseases, Immunology, Gastrointestinal, Vaccines, Respiratory, Cardiovascular and Endocrinology)
• Previous nominal practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company or CRO
• Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines
• Good command of written and spoken English language

Clinical Research Pre-award Professional Resume Examples & Samples

• Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution
• One (1) year of budget development, grant and/or contract experience
• Two (2) years of clinical research coordination experience
• Experience working as part of a multidisciplinary team
• Experience working with human subject research regulations
• Experience coordinating clinical research studies and reading clinical trial protocols
• Previous clinical trial budgeting, grant and/or contract experience
• Thorough understanding of UCD fiscal policy and the regulations set forth by sponsoring agencies
• Ability to change and/or develop departmental policies to ensure the department(s) is within compliance
• Independent judgment as well as self-directed work capabilities
• Ability to learn the University’s InfoEd system and procurement related functions
• Ability to interact with faculty, sponsors, PRAs, trainees, and the administrators on a regular basis. Communication will be across departmental and central administration lines
• Professional business conduct and an ability to maintain effective lines of communication are required
• Ability to prioritize and handle multiple competing deadlines is a must
• Proficient knowledge of Microsoft Excel and Word
• Individual must be very well organized, detail oriented, and able to work independently
• Working knowledge of human subject research regulations and experience coordinating clinical research studies and reading clinical trial protocols
• Experience with social science research
• Proficiency in positron emission tomography imaging software such as PMOD
• Proficiency with database management including REDCap
• Eagerness to learn image analysis techniques such as FreeSurfer, DtiStudio
• Strong knowledge of basic concepts in family planning, such as major contraceptive methods and clinical abortion methods
• Direct experience in a clinical setting where abortion is provided
• Experience in health education and/or counseling to family planning patients
• At least two years of direct clinical research experience

Specialist Clinical Research Monitor Resume Examples & Samples

• Conduct site qualification, initiation, remote and interim monitoring and study closeout visits under the guidance of the manager
• Be responsible for monitoring and reporting the progress of the trial and for verification of data
• Bachelor’s Degree, preferably in a clinical science/nutrition/nursing field or Associate's Degree/RN with relevant clinical experience is required
• One year of clinically-related experience in a medical profession, pharmaceutical, or diagnostic company
• Good planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
• Good written and verbal communication skills; attention to detail and strong interpersonal skills
• Good observational skills, analytical and conceptual capabilities
• Strong ability to work independently or with a team with minimal supervision
• The Monitor is accountable to Clinical Project Manager. The Monitor conducts clinical site monitoring visits according to the monitoring plan, ensuring Abbott studies are conducted according to all applicable regulations and business processes
• To work as part of an international clinical team which is led by the Clinical Trial Manager
• To be responsible for ensuring that, at the site level, the Clinical Monitoring Plan is implemented
• Ensure appropriate attention is provided to the sites in order to drive data quality so that the clinical study protocol requirements are fulfilled within the appropriate regulatory and ethical framework
• Excellent knowledge of Good Clinical Practice (GCP)
• A good working knowledge of conducting clinical trials in general and specifically in oncology, ideally including haematological oncology (ie. Lymphomas, leukemias etc)
• Fluency in both Italian and English (spoken and written) is essential
• Valid drivers’ licence and ability to travel throughout Czech Republic
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents
• Gains an in-depth understanding of the study protocol and related procedures
• Experience monitoring complex therapeutic studies such as Oncology, Cardiovascular, Infectious Disease, Transplant, etc
• Valid driver's license
• Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand technical information effectively
• Proven Skills in Site Management including management of site performance and patient recruitment
• Demonstrated high level of monitoring skill with independent professional judgment
• Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices
• Able to work highly independently across multiple protocols, sites and therapy areas
• Leads and coordinates research activities administered by OneFlorida Clinical Research Consortium. Meets with investigators and reviews potential protocols for fit, feasibility, and implementation for the consortium. Serves as the point person for the protocols and their development. Executes community-based pragmatic and implementation science research throughout the State of Florida. Directs the research and evaluation work conducted by the OneFlorida CRC team, both at the University of Florida and with teams housed in the OneFlorida CRC's academic, health system, and health payer partners throughout Florida. Ensures that systems are in place for the effective, efficient, and accurate conduct of funded studies and clinical trials
• Responsible for the ongoing workload assessment and reassignment of work as needed Manages resolution of problem solving for issues arising from the conduct of research activities and directly supervises day-to-day activities of the OneFlorida Integrated Clinical Research Program (ICRP) to include
• Work with the Maintenance of Certification coordinator to develop, implement and track research-based educational programs for community clinicians linked to OneFlorida--supported research projects and best practices. Assist with Maintenance of Certification and Continuing Medical Education program development
• Work with the ICRP Coordinator whom directly supervise the Practice Research Facilitation team and whom facilitates the Clinical Champions and Health System Engagement
• Supervise the OneFlorida IRB coordinator including: helping to develop workflow processes, track practice involvement in ICRP studies and monitor ICRP studies as they move through the OneFlorida IRB
• Works with the OneFlorida Leadership to develop research proposals and grant applications. Leads development of research proposals that will use the OneFlorida CRC infrastructure to conduct research with internal and external investigators. Works in conjunction with the PIs to develop research proposals that are scientifically rigorous, logistically feasible, and important to the OneFlorida CRC mission and membership. Works with the PIs and the OneFlorida Chief Operating Officer (COO) to create and execute budgets appropriately for the work proposed
• Facilitates coordination across projects and project partners to support statewide initiatives and research programs, including activities related to the CTSI and the OneFlorida CRC. Ensures that relationships with entities involved in the programs lead to appropriate levels of commitment and use of resources to achieve programmatic goals, performance metrics, and service delivery. Ensures the research team adheres to policies and procedures, meets compliance guidelines and goals are met within specified timelines
• Advises and coordinates with Program Directors and PIs regarding financial and operational planning, strategic planning, budgeting, auditing, program direction, project management, contract review, and supervision of associated administrative activities
• Acts as liaison for OneFlorida with partner, investigator, sponsor, and internal/external stakeholders. This includes but is not limited to conference exposition, presentations, and meetings as requested
• Responsible for understanding policies and procedures related to the programs, and developing and implementing procedures for the programs/service area
• Master's degree preferred in Social/Behavioral Sciences, Public Health, Health Services Research, Economics, or a related field
• Two years' experience in working within and/or conducting pragmatic, observational, and community-based health care projects
• Attention to detail, particularly with regard to implementing project protocols and in terms of collecting data to ensure data accuracy and integrity
• Ability to work independently and to collaborate with a variety of community leaders and members, health care providers, faculty and staff

Commercial Product Manager Life Sciences & Clinical Research Resume Examples & Samples

• Develop and implement business plans with specific regard to the category (e.g. Life Science) to ensure that European Product Management strategy is delivered at a local country level in an effective and appropriate manner. This includes language, pricing, sales force communication, supplier and marketing liaison. Processes should enable two-way communication, so that central strategies can be delivered locally, but also local market input can be fed back to the centre to ensure that strategies are executed in the most effective manner
• Candidates must have a bachelor’s degree in business, operations, or a scientific field. An advanced degree in business or science is preferred
• Candidates must have 3 - 5 years of progressive commercial experience and ideally experience in working in a customer facing environment for a similar time
• Potential candidates should have relevant experience in at least two (and preferably more) of the following areas

Clinical Research Study Specialist Resume Examples & Samples

• Proactive in identifying issues/project risks
• Strong communicator, written and verbal both internally, and externally (clinical sites and vendors)
• Scientifically minded; prior experience in protocol design and submission
• Join a stable team of 90 CRAs across Russia and benefit from outstanding training and development, both initially and throughout your career
• ONCOLOGY Focussed
• Minimum of one year of clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits)

RN Clinical Research Coordinator Resume Examples & Samples

• Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability
• In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly documents all findings
• May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians
• Attention to details and accuracy

Clinical Research Enrollment Assistant Resume Examples & Samples

• Clinical Research Coordinator, or RN/LPN with research/Data entry experience
• Proficient with computers including data entry, MS Office, and email
• Cardiology experience Required
• Experience with database, data management, FDA regulations, IRB requirements and the Stanford clinical research environment highly desirable
• Ability to determine workload priorities in an appropriate way to accomplish tasks and goals, meet deadlines and anticipate and solve potential problems
• Experience with patients or research subjects
• Experience with basic statistics
• Good oral and written communication skills to effectively work with physicians, clinical staff and other health care professionals
• Proficiency with Microsoft Office, Word, Excel and various industry-oriented electronic data capture programs
• Excellent organizational skills and attention to detail in maintaining accurate, retrievable records
• Strong computer programming skills (especially Matlab)
• Strong data analysis skills
• Experience with signal processing and statistics
• Experience with server maintenance
• 2 years of prior work experience
• Experience working on study protocol submissions and modifications
• Experience obtaining bio specimens and archiving samples
• Excellent oral communication skills to effectively work with other research and administrative support staff
• Ability to work well and communicate effectively with subjects and families
• Reads and understands clinical data from medical records. Extracts and enters required clinical data from medical records and patient research charts/reports to Clinical Research Forms (eCRFs/CRFs)
• Maintains currency of research regulations including rules concerning reporting of Serious Adverse Events (SAEs) and violations with department training and feedback
• Interfaces with sponsors of externally sponsored trials. Provides timely data entry, plans and organizes monitoring visits and responds to inquiries
• Performs follow up for study patient survival by reviewing medical records. Contacts other institutions for data on patients hospitalized at other institutions
• Interacts closely with quality assurance teams to ensure data accuracy on Clinical Research Forms (eCRFs/CRFs) prior to submission for in-house, National Cancer Institute (NCI) sponsored and Cooperative Group studies. Discerns basic data discrepancies/protocol violations. Assists in obtaining outside documents and study specimen procurement and handling
• Attends new protocol start-up orientations. Completes required protocol specific training
• Assists in preparation of audits of assigned studies such as National Cancer Institute (NCI), Food and Drug Administration (FDA) and pharmaceutical audits
• Completes spreadsheets for industry studies in real time to ensure sponsor is invoiced appropriately and timely
• Ensures confidentiality, accuracy, security and appropriate access of all data and records
• Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan
• Communicate visit findings with site personnel, ensure relevant follow-up
• Identify site needs, provide solutions to facilitate the clinical trial process
• Act as a primary point of contact for study sites as requested
• Assist in initial and ongoing site personnel training as required
• Attend Investigator and/or Coordinator meetings
• Lead all relevant monitor responsibilities

Rtg-clinical Research & Medical Evidence Specialist Resume Examples & Samples

• Bachelor’s degree in life sciences or other technical discipline
• Experience in clinical research, specifically in clinical project management and governance
• Knowledge of local evidence needs, laws & regulations, including Good Clinical Practice, NHMRC, MTAA and TGA guidelines
• Knowledge of clinical monitoring functions, scientific or clinical research and the scientific method, including study design and implementation
• Masters or PhD preferred
• Strategically and clinically minded with an eye on the bigger picture
• Driven, reliable and resilient with a “can do” attitude
• Ability to understand mindsets of other stakeholders in commercial and functional roles and speak their language
• Customer-focused with a clear record that demonstrates the ability to build solid relationships with external and internal stakeholders at all levels
• Team-oriented, outgoing, collaborative and friendly
• Strong judgment and interpersonal skills
• Ability to work effectively whether independently/ unsupervised or in cross-functional teams and in a matrix organisation
• Able to prioritise, handle multiple tasks and work under pressure
• Strong communication and presentation skills. Ability to understand and communicate complex concepts and ideas in a way that connects and engages the audience
• Personal passion for sharing knowledge and facilitating the development of others
• Excellent organizational and project management skills
• Attention to detail
• Model Medtronic Leadership Expectations & Behaviours
• Shape: Committed to being experts in what we do, with a clear vision of where we are going and the plan to get there - Thinks critically and makes sound decisions by engraining “patients, people and profits” as the way we prioritize & drive decision making
• Engage: Partner with others knowing that diverse talent, skills & perspectives lead to better outcomes – foster an environment of diversity, inclusion and engagement
• Innovate: Bold thinker who creates new ideas and bring out best solutions forward to benefit out patients, and customers – generate breakthrough ideas by creating an environment that supports experimentation, and responsible risk taking
• Achieve: We do what we say we are going to do, delivering results with the highest standards – drive accountability, start by establishing your personal brand, for delivering results

MC Clinical Research Monitor SH Resume Examples & Samples

• Bachelor’s degree (technical). Technical degree defined as engineering, biological sciences or related medical/scientific field. Masters degree will substitute for 1 year of experience. A PhD or MD will substitute for 2 years of experience
• 8+ years’ experience in device, biotechnical and/or pharmaceutical industry clinical trials
• Familiar with Medical Device and/or combination product trials and regulations
• Expertise with GCPs and regulatory and compliance guidelines for clinical trials
• Significant knowledge of clinical and outcomes research study design
• Demonstrated ability to work effectively on cross-functional teams
• Local language and English skills
• Experience working with customers
• Ability to deal with complexity and ambiguity even in the face of adversity
• DESIRED/PREFERRED QUALIFICATIONS
• Advanced Degree MS or PhD or MD
• Experience in conducting clinical trials in cardiovascular therapeutic indications

Clinical Research Prin Program Resume Examples & Samples

• 10+years project/program management in a high tech or medical industry
• 10+ years experience successfully implementing substantial projects
• 5 years progressive leadership experience
• MBA or masters degreeIT/ BioMedical / Project Management
• Expertise with MS Office (particulary Excel, Word, Powerpoint)
• Experience developing end user programs (training, communications, technology initiatives)
• Fiscal management, budget tracking, and reporting skills
• Previous experience succeeding in a global organization
• Global Mindset
• Change Management experience

Clinical Research Monitor Germany Resume Examples & Samples

• Two years Clinical Research experience (one year of Clinical Monitoring preferred)
• Expertise in GCP, ISO 14155 (preferably) and regulatory requirements in Germany/Austria
• Business knowledge or experience within the medical/healthcare industry

Analyst, Clinical Research Resume Examples & Samples

• Works with Director of Country Operations to design and operationalize a strategy for data analysis and visualization supporting the region
• Assess data coming into and exiting the country and presented to project teams, headquarters or other interested parties for appropriate accuracy, fit, impact analysis, and presentation
• Supports country leadership team with data analysis and presentation for reporting and infrastructure measures to operationalize country strategy including: problem assessment, project planning, project implementation and assurance of ongoing project maintenance and monitoring
• Works closely with CRDs, Head of Site Account Managers and Head of COMs in the provision of metrics and measurements that monitor country performance or specific country/project initiatives
• Runs alternative scenarios/Impact analysis when supporting managers for country manpower/human resources assessments or determining individual trial human resource needs
• Conducts all analysis/assessments/reports utilizing appropriate fiduciary principles supported by company and country leadership team
• Works cooperatively with all headquarters based colleagues collecting and tracking country and global performance
• Maintains knowledge and awareness of all new Merck systems for understanding reporting and analytical capabilities
• Fluency in Microsoft Excel
• Fluency in presentation/analytics Business Intelligence (BI) software packages (may include SpotFire, Clik, Tableau, or other similar tools)
• Proven track record in supporting data/metric collections, data organization, data cleaning, data analysis, data visualization and presentation
• Knowledge, awareness, and experience in clinical trial operations in a pharmaceutical company
• Oversee participant recruitment activities and maintain participant tracking systems
• Oversee data collection, analysis, and presentation
• Assist PIs in planning and preparation of presentations of research findings, including writing and editing reports and articles for publication
• Assist PIs in development of grant proposals and manuscripts, including proposals for new and/or continued research activities
• Hire, train, and supervise project personnel; develop and manage project teams and team meetings
• Develop timelines and project schedules; develop process documentation; ensure that all human subject protections are in place; oversee and monitor project budget
• A bachelor’s degree in health related field, preferably in nursing or public health is required; Master’s degree preferred
• One (1) to three (3) years of demonstrated work experience on research projects with vulnerable subjects and project administration and the ability to manage research protocols and data
• Is or has the ability to become PEERRS certified
• Experience with reporting software and interpreting analysis
• Candidate must have excellent oral and written communication skills, attention to detail, strong interpersonal skills, and organizational skills
• Demonstrated proficiency with Microsoft Office products (including Outlook, Word, Excel, and PowerPoint); expertise with reporting software and interpreting analysis

Research Assistant Clinical Research Resume Examples & Samples

• Administer questionnaires, and assists with procedures for obtaining patient screening and recruitment as well as obtaining research specimens
• Assist in obtaining educational resources necessary to perform and interpret research and to remain abreast in research area of function
• Maintain a safe clean laboratory-working environment including appropriate equipment maintenance and usage, by conforming to laboratory and hospital policies and standards
• Maintain laboratory inventory, including timely ordering and receipt of required supplies and their proper storage
• Perform approved research projects according to defined protocols and procedures including appropriate collection, recording, storage and analysis of data and reporting of results
• Prepare, label, store and disposesof reagents, and calibrates equipment for research projects
• When position is required to work within the outpatient clinic, assist with patient care activities to ensure efficient and appropriate service
• Bachelor of Science degree in chemistry, biology or other basic science or Bachelor of Arts degree in a science or health related field with a minimum of 15 credit hours in related science courses
• Interest in clinical research and women's health issues is strongly preferred
• Manual dexterity and visual acuity necessary for handling and processing specimens for testing, including preparation of specimens, operation of laboratory equipment, microscopic examination, etc
• Demonstrated ability to accurately collect, store and interpret research data
• Demonstrated ability to communicate with patients, staff and investigators

Certified Clinical Research Coordinator Resume Examples & Samples

• Interprets complex clinical research data
• May prepare and ensure grant applications, IRB / GCO documents are submitted
• May obtain informed consent under general supervision of the Investigator(s) and educate participants regarding study requirements

Medical Assistant, Clinical Research Center Resume Examples & Samples

• Checking schedules and organizing patient flow; accompanying patients to exam/procedure room, assisting patients as needed with walking, transferring, dressing, collecting processing specimens and point of care testing, preparing for exam, etc
• Assists physicians with various procedures, takes vital signs, relays instructions to patients and or families; answers calls and provides pertinent information
• Fulfills clerical responsibilities as assigned which may include sending and receiving patient medical records, obtaining lab or x-ray reports, hospital notes, referral information, etc. Completing forms and requisitions as needed, managing charts to ensure information is completed and filed appropriately
• These responsibilities may be carried out using the electronic medical record (EMR) system or manually as necessary
• Enters orders into the electronic medical record (EMR) system or prepares prescription refill requests on behalf of the physician for the review and approval by the ordering physician
• Inventories, orders or re-stocks medical supplies as applicable
• Provides set-up of examination room and instruments in accordance with proper sterilization techniques established by hospital and infection control policies
• Maintains logging system as required for refrigeration of medications, point of care testing, sterilization process, crash cart or others as needed
• Checks expiration dates on all medications and medical supplies disposing appropriately as per institution policy
• Maintains a safe, secure, and healthy work environment by following standards and procedures and in compliance with legal regulations
• Complies with established personal protective equipment requirements necessary for protection against exposure to blood and other potentially infections body fluids, chemical disinfectants, radiation and other hazardous substances
• Assists in the maintenance of medical charts (filing, Op Reports, test results, home care forms)
• May schedule surgeries/procedures or work in conjunction with Surgical Coordinator verifying times with patients; preparing charts, pre-admissions and consent forms as necessary
• May be required to perform proficient phlebotomy duties
• May perform appointment scheduling and registration for patients as well as updating patient demographic and insurance information
• May maintain, adjust and confirm patient office schedule
• May check and verify & update insurance information utilizing internal or web sources
• May perform and verify pre-certification for procedures as necessary
• Provides training and mentoring to Level I MA staff
• Directs and assigns MA schedules and work flow to meet the needs of the practice and applicable to patient volumes
• Oversee the successful delivery of clinical office support to meet the needs of each physician
• Performs other duties and tasks as required

Associate Clinical Research Coordinator Resume Examples & Samples

• Assists with the collection, maintenance, and storage of relevant clinical data including electronic data entry, case report forms, patient follow-up and regulatory binders in accordance with the study sponsor and all regulatory bodies
• Assists with the planning and coordination of regulatory activities pertinent to clinical trial operations, including but not limited to: interfacing with local and central IRBs, assuring patient safety and organizational compliance with institutional, local, state and Federal policies/procedures, regulations, guidelines, and laws
• Assists senior-level research coordinator staff with patient screening, education, consenting, monitoring, and evaluation for protocol accrual

Clinical Research Coordinator Pediatrics Resume Examples & Samples

• Ethical and participant safety considerations. Maintainfamiliarity with the ethical conduct of research and safeguards neededwhen conducting research.Train junior staff in the ethical conduct of research. May help in thedesign of studies so theyinclude specific safeguards to ensure ethical conduct and protectvulnerable populations.May develop, or assist with the development of, documents related tosafety and security.Communicate to research participants the difference between clinicalactivities and researchactivities, and the risks and benefits of study participation
• Data management and informatics. Use and train others inElectronic Data Capture (EDC) systems, technologies, and softwarenecessary for studyoperations.Score tests, enter data, and complete Case Report Forms accurately andaccording to protocol.Assistwith the development of, or develop, data collection documents andinstruments. Detect issuesrelated to data capture, collection or management; suggest solutions.Investigate incomplete, inaccurate, or missing data/documents to ensureaccuracy andcompleteness ofdata; follow and develop, or assist with development of, SOPs for dataquality assurance. Adheretoprocesses and run queries, summaries, and reports to monitor thequality of data. May develop QAprocesses and oversee the creation and use of queries, summaries, andreports for qualityassurancepurposes. May be responsible for recognizing trends related to dataquality and escalating asappropriate.Map protocol data flow. Predict areas of vulnerability for a protocoldata flow plan. Determineareas where data provenance may be compromised and develop solutions.Recognize when data agreements or special regulatory requirements arenecessary; mayassemble thenecessary parties to ensure that all agreements are in place
• Scientific concepts and research design. Understand and train othersin the basic concepts ofstudy design. Independently conduct literature reviews. Assist with thedevelopment of, or develop,proposals or protocols; identify shortcomings of proposals andprotocols.Identify various stakeholders (statistical, operational, etc.) toensure adequate design,implementation, and testing of study aims. May determineoperational/statistical elements neededforconduct of clinical and translational studies
• Leadership and professionalism. Assist research colleagues inidentifying efficiencies andimproving process. Successfully take part in or lead a committee ortask force. Actively seek outcontinuing education opportunities for self and study team members.Participate in or leadscientific presentations and publications.Assign, review, and train others in various work responsibilities.Serve as a mentor to juniorstaff, including other CRCs. Employ escalation and performance plans asneeded.Recognize and employ the professional guidelines and code of ethicsrelated to the conduct ofclinical research; summarize and clarify for study teams. May beresponsible for identifyingpotential problems and risks to the participants, study, and institution
• Study and site management. Participate in sponsor-requiredtraining. Obtain information for or coordinate operational plans formultiple research studies. Develop protocol-specific systems and documents including processflows, training manuals,SOPs, andCRFs.Ensure participant care expenses have appropriate financial routing.Monitor financial studymilestones and report appropriately. Coordinate with financial teams,PRMO, etc. Assist withstudybudgets.Prepare for, take part in, and potentially lead site initiation,monitoring, closeout visits, anddocument storage activities.Collect information to determine feasibility, recruitment and retentionstrategies. May makerecommendations to investigators and oversightorganization(s).Maintain compliance with institutional requirements and policies.Oversee maintenance ofDelegationof Authority Logs and training of KP on study specific duties
• Communication and team science. Prepare for and lead teammeetings. Take an active role in including others in decision-making,and escalate issuesappropriately.Communicate with sponsors, subcontractors, or vendors. May be responsible for taking action when communication has stalled with sites, CROs, sponsors.Maintain Duke and project specific training requirements. Develop solutions to proactively ensure study team members' compliance with training requirements.Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team

Clinical Research Team Manager Resume Examples & Samples

• Actively involved in the recruitment, hiring, orientation, ongoing training, and retention of CRSO staff. Supervise and guide a team of clinical research coordinators through established problem solving process for setting up and maintaining clinical research projects. Monitor outcomes and suggest departmental changes to make training and management process more effective and/or efficient. Identify areas for improvement and make recommendations for re-allotment of resources, as needed
• Performs ongoing performance management activities including the ImPACT evaluation. Ensures staff is appropriately trained to perform the tasks delegated to them, and ensures staff have appropriate required skills, e.g., CPR, to perform job responsibilities
• Assist CRSO leadership in evaluating new study protocols and current staff workloads to assist in determining the distribution of new projects/workloads
• Develop and maintain tools, processes, programs, and standard operating procedures (SOPs) designed to support the conduct of clinical research
• Quality Assurance: Work with Principal Investigators to ensure Regulatory and Institutional Compliance for all study protocols supported by direct reports
• Assure appropriate regulatory compliance, IRB approval and renewal, and appropriate training of all research personnel
• Ensure coordinators are adhering to best practices including confirmation of subject eligibility, proper informed consent process & documentation, and protocol adherence
• Conduct quality assurance reviews/audits on CRSO-supported projects to ensure protocol compliance, accuracy of data collection, adherence to regulations and applicable good clinical practice guidelines. Audit reports will be created and submitted to Associate Director and Director
• PI satisfaction: Ensure team coordinators meet with and maintain weekly communication with all study PIs regarding study progress, status, enrollment and other pertinent issues, as necessary. Team Manager should attend these meetings as needed
• Clinical Research Budgets and Billing Compliance: In collaboration with the Associate Director CRSO and Clinical Trials Financial Management (CTFM), assist in the development of staffing budgets that appropriately cover costs of study implementation. Also monitors to ensure billing compliance through adherence to CHOP research billing processes
• Trial Enrollment: Work with coordinators and PIs to strategize recruitment methods for studies to ensure accrual objectives are met
• Quality Improvement Initiatives: Work with CRSO management team to identify, develop, and implement quality improvement initiatives
• As a member of the CRSO management team, provide administrative leadership and oversight to coordinators, , including guidance on GCP, protocol conduct, etc. and provide pertinent updates to Associate Director and Director in a timely manner
• Demonstrate an ability to lead and motivate team members with vision, integrity, and flexibility
• Work with Director and Associate Director to develop, organize, maintain, and manage the infrastructure and resources necessary for supporting quality clinical research
• Participate in Research Institute-sponsored education and training activities as requested
• Bachelor’s Degree with minimum 7-9 years clinical research experience or a Masters Degree in Public Health (or related field) with at least 5-7 years clinical research experience
• Experience with IND or IDE clinical trials
• Demonstrated ability to work independently and drive processes
• Demonstrated ability to manage projects and/or teams
• Registered Nurse (RN) in the state of Pennsylvania preferred
• Pediatric experience preferred
• Ensuring adverse events and protocol deviations are reported in an efficient manner
• Ensuring that device complaints and malfunctions are reported according to SJM Policies and Procedures
• Coordinates with study teams, field clinical engineers or designee to: Enroll sites into new and ongoing clinical studies - Facilitate enrollment of study subjects via site coordinators - Facilitate resolution of data queries and action items at clinical sites - Promptly reports the findings of monitoring visits according to SJM processes
• Participates in conference calls and training sessions
• Mentors less experienced clinical team members as requested
• A Bachelor’s degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field
• Minimum two years clinical research monitoring experience
• Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees
• Previous related experience in a medical device/pharmaceutical company or relevant clinical experience in a clinical/hospital environment
• Minimum of five (5) years broad scope clinical experience required
• Certification in Healthcare Quality, Managed Care, HIAA, Credential, Risk Management or Legal Nurse Consultant preferred
• Demonstrate familiarity with applicable regulatory guidelines and requirements (URAC, EQRO), with at least two years managed care experience, experience with regulatory or accrediting body requirements and Clinical Quality Improvement experience preferred
• Prior experience with Home Health, Quality Improvement, Health Risk Management or Legal Nurse Consulting preferred
• Possess an understanding of broad range of business needs, goals and objectives and the potential impacts of each, including but not limited to Contracts and Network Management, Legal, Member Services, Complaints and Grievances, Utilization Management, Population Health, CHOICES and Credentialing
• Demonstrate effective written and verbal communication skills
• Must be self-motivated and able to manage multiple task and priorities within specified timeframes
• Proven PC skills with Microsoft Office, specifically Word and Excel
• Strong analytical skills with understanding of basic statistics required
• Demonstrate proficiency in medical record review and creation of medical chronologies for case review
• The ability to analyze and interpret data for standard of care with presentation to a varied audience
• Demonstrate excellent logic, systematic and critical problem solving skills
• Demonstrate proficiency with computers and diverse software packages

Clinical Research Prog Lead Resume Examples & Samples

• Bachelor's or advanced degree preferred in nursing, biology or other health science field, operations research, or other related field, or equivalency
• Minimum five (5) years' experience and demonstrated skills to successfully perform the assigned duties and responsibilities, i.e. coordinating research projects under specific guidance, training and/or experience in research methodology/research study design, hypothesis testing; OR experience in clinical trials protocols involving research methodology/research study design, and hypothesis testing
• Five (5) years of progressive leadership experience preferably in the clinical research industry
• Advanced knowledge and understanding of regulatory guidelines related to human subject research protections in clinical trial investigations
• Ability to assess functional processes, workflow and develop documented improvement plans for efficiency and quality output
• Advanced knowledge of industry standards related to clinical trial coordinator functions and study data management activities; (i.e., complex trial designs, data standards, data reviews, etc.)
• Clinical Trial Management Software experience (i.e., Clinical Conductor, OnCore, Velos)
• Demonstrated ability to positively influence others in a team environment
• Proactive and critical evaluation of multiple aspects of clinical trial execution Background knowledge of assigned department's area of specialization
• Attention to detail; strong interpersonal and collaborative skills; excellent, effective verbal and written communication skills and the ability to multi-task in a fast-paced environment while working with a diverse subject population
• Proficient in Excel, PowerPoint, and graphics programs
• Health Information and Accountability Act (HIPAA)
• CHR regulations for recruitment and consent of research subjects
• Accountable for the management of the Clinical Research Department and all direct reports
• Conducts interviews, makes hiring decisions in conjunction with senior management, ensures adequate staffing, and conducts training, orientation, and mentoring of new employees
• Assists in the development of the team’s goals and performance metrics and the analysis of established objectives
• Effectively communicates performance metrics to the clinical research team and ensures training needs are met
• Conducts the performance evaluations of direct reports, addresses noncompliance, and recommends corrective measures through progressive performance management
• Collaborates with planning and scheduling teams to ensure effective utilization of study resources
• Participates in study initiation and audit meetings for project team assignments
• Establishes quality standards for the department, identifies opportunities for improvement, and recommends updated standards
• Responsible for the development, maintenance, and revision of Standard Operating Procedures and study specific procedures
• Works closely with other departments to maintain project progress and issue resolution through weekly meetings and tracking tools
• Reviews upcoming projects for feasibility and assists with resource planning to meet study requirements
• Participates in the review of pre-study documents as necessary to ensure protocol compliance and quality
• Closely monitors the progress of each clinical study team to ensure consistency and quality in performance
• Acts as a liaison with the sponsor as necessary
• Represents the organization, both internally and externally, as a source of consultation, information, and expertise
• Provides input and ensures compliance to department budget requirements, including budgeted study hours

Principal Clinical Research Associate Resume Examples & Samples

• Provides leadership in complex clinical research activities including: reaching agreement on study goals with other functional areas, coordinating and overseeing study monitors and investigators to ensure compliance, monitoring, analyzing and interpreting study data, and preparing reports
• May contribute to the design of clinical studies. Independently plans and implements complex or significant clinical research studies and projects
• Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organization
• Plans own work assignments; may plan and/or delegate work to others
• Assumes responsibility for coordinating the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific objectives
• Maintains a high level of professional expertise through familiarity with scientific literature, RMS product portfolio and competitive environment
• Travels to field sites to monitor studies or coach and train co-workers at the CRA level and below
• Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
• May recruit, train, and manage co-workers and contract workers for specific projects
• Collects and maintains legal and regulatory documentation, as applicable
• Coordinates or conducts reference material testing in-house
• Organizes investigators meetings, as necessary
• May represent the Company as primary contact on projects
• Interacts with senior management from other RMD departments or Roche companies on significant matters often requiring coordination between departments/organizations
• May lead project teams to solve business problems of moderate size risk and complexity
• Assists investigators with publication activities
• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research
• Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators
• Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function
• Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment
• Demonstrated business ethics and integrity

Clinical Research & Laboratory Operation Manager Resume Examples & Samples

• Apply project management best practices in the development, initiation, planning, execution, control and closing of project
• Manage the research administration of the projects. Manage budget and maintain accounts
• Oversee adherence to SOPs, Good Clinical Practice and FDA regulations
• Assist the PI on the review of agreements, MTAs, DTAs, patents and other documents
• Develop and maintain program timeline and actively manage project progress
• Define problems, troubleshoot, and identify potential solutions
• Problem solve at a strategic level and work well with others to reach solutions, careful planning to achieve accurate and timely results, and the ability to work independently and well under pressure to ensure tasks are prioritized to meet aggressive deadlines
• The CIBS Brinton Laboratory and Clinical Research Operation Manager will work directly with the PI, Brinton research laboratory staff and Clinical Operations Director
• Bachelor’s of Science degree
• Five (5) years experience in clinical trial, research and grant proposal preparation and management
• Two (2) years’ experience managing multidisciplinary projects
• Five (5) years experience managing multidisciplinary projects
• Excellent negotiating skills
• Experience in laboratory equipment procurement
• Demonstrated ability to analyze information, situations, problems, policies and procedures and adjust strategic decisions and course corrections as a result
• Ability to work independently and under pressure in an innovative academic environment with minimal supervision
• Ability to establish and maintain cooperative working relationships with vendors, staff, program leaders, and administrators
• Track record of managing multiple concurrent tasks, responsibilities, and changing priorities, while maintaining personal momentum and effectiveness
• Excellent organizational, critical thinking, and decision making skills
• Track record of successfully executing multifaceted projects, hitting deadline
• M.D. degree
• Two or more years of clinical research experience and/or basic science research
• Accredited fellowship in Cardiology, board certified or equivalent
• 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities
• Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company), preferably in dyslipidemia, cardiology, or endocrinology
• Provides strategic direction for clinical research office, to include establishing short and long term goals and desired outcomes
• Provides expertise in planning, analysis, and reporting key departmental metrics related to clinical trial performance
• Provides leadership and guidance on clinical research grants/contracts management
• Responsible for achieving financial objectives for the research office, including: preparation of annual budgets for clinical research needs, justification of and approval for research office expenditures, analysis of labor cost variances (budgeted vs. actual), and routine communication of findings to departmental leadership
• Collaborate with department and campus entities in the negotiation, coordination, administration and clinical trial contracts; ensure review of clinical trial agreements and sponsor budgets to ensure language of exhibit agrees with the main body of the clinical trial agreement
• Responsible for clinical trial tracking systems for management of clinical trials to ensure adequate and appropriate workflow assignments for clinical research office personnel and appropriate resource utilization
• Responsible for the framework of the departments overall clinical research office infrastructure
• Management and oversight of staff at multiple locations of geographically distributed locations, including hiring, training, managing, performance assessment, mentoring of supervisors, professional & support staff. Initiates, influences & creates developmental opportunities for staff. Oversee space utilization and allocation as needed
• Prepare coordinate, and maintain program content and delivery methods for daily operations and events within the department’s clinical research operations
• Ensure that all protocols and study budgets are reviewed for feasibility prior to their submission to the department Executive Research Council and campus entities
• Examine and evaluate program effectiveness, and makes changes as necessary
• Develop, maintain, and implement policies and/or services by establishing standards operating procedures compliant with federal and state regulations, measuring results against standards and making necessary adjustments. Regularly review and maintain familiarity with current policies and procedures
• Critically analyze performance data (audit and monitor findings) to monitor and evaluate effectiveness of policies revising program operating policies and procedures as needed
• Organize and/or participate in various committees and teams to consult with program heads and administrative officials on policy and program needs as well as various administrative issues
• Coordinate the regular publication of summary reports and serve as an information resource to coworkers, the department, the university, and external figures
• Participate in the development and coordination of protocols, informed consent forms, investigator brochures, clinical study reports, IND annual reports, and other documents, to ensure a thorough understanding of the goals and objectives of the proposed study
• Manage the conduct of single and multicenter studies, including site selection, development of monitoring plan, communication plan, site budgets, and investigator meeting. Present protocol at investigator meeting. Develop study-specific EDC system and manage timeline of creation of the database before study start
• Effectively manage the clinical staff (e.g., clinical research associates, administrative assistants) assigned to the study in order to meet study objectives
• Lead and direct the study team, which includes individuals from various clinical and functional departments. The number of team members varies dependent upon the phase and complexity of the study
• Maintain relevant FIPCUS internal tracking systems, including all clinical study management systems, by communicating with and obtaining input from the individuals and departments involved
• Review and approve all study expenditures and bills, coordinating with the accounting department. Ensure decisions are made according to plan
• Maintain ongoing communication with FIPCUS management regarding study progress, enrollment, and any problems encountered during the study. Trouble-shoot throughout the course of the study to resolve any issues arising at study sites, or with monitors and CROs
• Travel to sites and other Ferring facilities as required
• Ensure that the conduct of all studies follow local or global Ferring SOPs and regulatory requirements
• Develop, negotiate and track study budgets and contracts including those pertaining to: CRO, Lab vendor, Sites, other miscellaneous vendors
• Ensure clinical trial management systems containing all site-specific information are maintained and kept current. Provide Local regulatory and legal requirement expertise. Ensures timely payment execution for the assigned sites/study(s) according to the clinical study agreements and as per local requirements
• If assigned; Global Representative for a single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials
• If assigned; Responsible for remote data review of assigned sites/studies according to the Integrated Data Review Plan (IDRP), Monitoring Plan, SOP/WI and in accordance with the study timelines and objectives. Provides feedback on investigators/sites on an on-going basis based on the site performance. Interacts and builds professional and collaborative relationships with peers and site monitors

In House CRA Needed for Clinical Research Site Resume Examples & Samples

• Ensures adherence to Compass policies and SOP’s
• Performs compliance reviews on informed consent process documentation
• Performs compliance reviews to ensure accuracy of inclusion/exclusion criteria to confirm Subject’s eligibility for participation prior to randomization
• Performs compliance reviews on staff performance as it relates to adherence to protocol screening and randomization requirements and associated documentation
• Performs routine and/or random compliance checks on overall study performance as directed
• Excellent interpersonal and communication skills (written and oral)
• Knowledgeable with Microsoft Office
• Strong planning and organizational skills
• Takes initiative
• Minimum HS Diploma and/or GED Transcript
• Minimum of2 years clinical research experience required

Clinical Research Comm Specialist Resume Examples & Samples

• Identify, plan, and develop a range of digital and printed materials to support trial and project engagement among key stakeholders
• Review and provide input on patient recruitment and retention plans; suggest innovative strategies to meet recruitment and retention challenges; engage critical stakeholders in DCRI-led projects
• Provide input on technologic applications to optimize participant recruitment and facilitate site study operations and performance
• Research social media and other trending technologies and suggest appropriate tactics to improve stakeholder engagement
• Manage the translation process of relevant materials to reach diverse populations
• Act as the team liaison for developing and finalizing content and relaying input on design and formatting options
• Manage timelines and ensure that all materials are completed to the satisfaction of the DCRI clinical operation teams, principal investigators, and clients and are in compliance with relevant regulations, standard processes, policies, and procedures
• Review and provide input during case report form (CRF) development
• Collaborate with Clinical Data Management, Statistics, and Clinical Operations to create CRF guidelines/instructions. Maintain and update project and CRF terms databases
• Provide input for the development of proposals for new work and project budgets
• Collaborate with other functional groups within the organization to support project goals
• Track and report feedback received to identify areas of success and improvement
• Knowledge and experience in the coordination, planning, and implementation of communication strategies and tactics
• Comprehensive therapeutic knowledge, including medical terminology
• Working knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Ability to understand and interpret clinical protocols and associated study specifications
• Expertise in translating scientific, medical and complex concepts into more easily understood terms for various audiences
• Strong communication and interpersonal skills, including a good command of the English language
• Demonstrated ability to deliver quality results
• Good team leadership skills
• Strong software and computer skills, including proficient use of MS Word, WordPress, and Adobe Acrobat; SnagIt experience preferred

Clinical Research Navigator Resume Examples & Samples

• Ensure Investigators and study teams are able to identify and connect with required resources within UMMS or UMMHC to accomplish research goals
• Facilitate the connection to core services and develop and maintain standardized processes and guidance information on resource navigation necessary for implementation and performance of clinical research
• Develop resources for and assist in connection of industry initiated study opportunities to appropriate Principal Investigator and study teams
• Be the principal point of contact for the NIH Trial Innovation Network, assisting investigators in the conduct of multi-site NIH sponsored clinical trials
• Define key strategies for optimizing cross-system efficiencies and shared policy development priorities, including research billing compliance
• Collaborate with Director on assessment of existing Standard Operating Procedures and development of needed SOPs, including Good Clinical Practice
• Serve as key resource and subject matter expert on the clinical trial management system and electronic medical records systems as related to research
• Represent UMMS clinical research initiatives in cross-team and cross-institution working groups related to clinical research implementation in the UMMHC environment and inform parties regarding standard research practices
• Advise and consult with clinical investigators and clinical research staff on individual study projects, focusing on feasibility, initiation issues and best practices
• Support education and awareness on clinical research billing requirements for appropriate research billing
• Advise investigators on navigation of the Investigational New Drug/Investigational New Device application process
• Serve as a resource for OCR staff and study teams related to assessment of clinical costs in clinical research budgets
• Bachelor degree in a health-related field, or equivalent experience
• 5 years of clinical study coordination or study management experience (drugs, devices)
• Understanding of federal, state regulations and guidance related to clinical research
• Understanding of Good Clinical Practice guidelines
• Understanding of Clinical Research Billing requirements
• Ability to work independently on multiple projects and prioritize confidential issues
• Superior communication, organizational and interpersonal skills, attention to detail and ability to facilitate cross-system decisions
• Ability to problem-solve and work under pressure in a deadline-driven environment
• RN or Master’s degree in health-related field
• Experience in an academic health center or hospital
• Understanding of the Investigational New Drug/Investigational New Device application process
• Certification as research coordinator or in other research domain preferred (CCRA, CIP)

Coord, Clinical Research Resume Examples & Samples

• Participate in the development of protocol specific tools, (e.g., treatment data and/or therapeutic checklists) to aid with data submission
• Extract and transcribe treatment data from hospital and clinical records required to complete study patient’s record and sponsor’s case report forms. Monitors quality and timelines of data submissions
• Monitor status of all studies in database and ensures that all patient data (on-study and follow-up) are submitted, and respond to data queries from sponsoring organization, in a timely manner
• Track and maintain accurate data of studies, accrual, and patient status activity in database
• Maintain effective working relationships with research nurses and investigators participating in the study
• Monitor strict adherence to protocols. Assure that cases are being finalized and reviewed by appropriate clinician
• Review protocol requirements with physicians and research nurses. Identify and resolve issues with protocol compliance. Keep principal investigator and research nurse aware of any issues on compliance
• Ensure that protocol document has current amendments. Inform staff and updates database
• Provide data to study investigators as requested and submits data for analysis. Run quality control checks on data prior to transfer
• Serves as a resource to physician and nurses to locate information for special reports and treatment decisions
• Adheres to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Participate in all office staff meetings. Present current status of studies assigned
• Participate in regularly held Protocol Review Committee meetings
• Participate in the documenting work procedures specific to new studies
• Perform other duties as required
• Bachelor’s degree in a scientific or health care field, or equivalent experience
• 1-3 years experience in on-study data management and data collection in a research organization
• Ability to read and understand complex protocols
• Excellent computer skills including: proficiency in word processing; proficiency in relational databases
• High degree or organizational and analytical ability to manage data collection and protocol adherence
• Excellent interpersonal and oral communication skills
• Good writing skills with the ability to compose correspondence
• Provide support to project through implementation of work plans, and preparation of deliverables. Assist in the documentation of project writing and preparation of material for project meetings
• Review treatment protocols as they are developed to ensure that the treatment guidelines are consistent throughout the document and the appropriate documentation for the central reviews of research intervention as specified
• Develop protocol specific tools (e.g., treatment data and/or therapeutic checklists) to aid with data collection and submission
• Set up the protocol treatment template in the department’s database by abstracting the details of the protocol to aid in on-study patient tracking
• Monitors status of all studies in the database and ensures that all patient data (on-study and follow-up) are submitted, and responds to data queries from sponsoring organization, in a timely manner
• Maintains effective working relationships with research nurses and investigators participating in the study
• Monitors strict adherence to protocols. Assures that cases are being finalized and reviewed by appropriate clinician
• Prepares regular reports reviewing the status of the study. Reviews protocol requirements with physicians and research nurses. Identifies and resolve issues with protocol compliance. Keeps principal investigator and research nurse aware of any issues on compliance
• Monitors notices from the Cooperative Group to ensure that protocol document has current amendments. Informs staff and updates database
• Provides data to study investigators as requested and submits data to the Cooperative Groups for analysis. Runs quality control checks on data prior to transfer
• Participates in all office staff meetings. Presents current status of studies assigned
• Participates in regularly held Protocol Review Committee meetings
• Participates in the documenting work procedures specific to new studies
• 3-5 years experience in on-study data management and data collection in a research organization
• Familiarity with clinical trials highly desirable
• Professional certification in clinical research highly desirable; otherwise, attainment of certification required within two years of hire
• Selects principal investigator and sub-investigator staff with National Senior Director, Clinical Research Operations
• Evaluates new protocols with selected principal investigator for potential new studies
• Negotiates contracts and prepares budget for new studies
• Oversees the preparation and maintenance of regulatory documents for new studies
• Follows-up with sponsor/CRO grants and contracts office regarding clinical trial agreements and indemnification letters
• Plans and designs new forms/source document tools to be used in protocol implementation
• Coordinates activities for tracking financial with the Accounting department including A/P and A/R
• Hires, trains and evaluates productivity and quality of work of clinical research staff using the annual performance appraisal
• Develops a plan for resource allocation including budget preparation for program and staff needs
• Assures that all aspects of the clinical research program is in compliance with current FDA regulations
• Coordinates sponsor site visits with research staff
• Complies with any and all reasonable requests in the event of a possible FDA audit and site visit
• Maintains all clinical research records in a safe and permanent location to comply with FDA regulations
• Generates reports for the National Senior Director, Clinical Research Operations
• Preferred: Over 10 years of management experience
• Working knowledge of Microsoft applications (Word, Excel, PowerPoint)
• Knowledge of medical billing and office automation software

Werkstudent Clinical Research Resume Examples & Samples

• Assistance in preparations for inspections and audits
• Fee settlement for clinical trials
• Scanning, archiving and delivery of study relevant original documents in the central
• Review and updating of databases (Excel, Word, Access)
• Document translations (German-English)
• Planning and organizing meetings (external and internal)
• Strong identification with the values of Celgene
• Enjoy office work
• Fluency in German and English
• Good to excellent Microsoft Office skills, especially Excel
• Thoroughness, attention to detail
• Interest in clinical trials
• Ensures that goals and activities of own work or project team is aligned with the objectives of the area(s) and the organizaiton
• Plans owns work assignments; may plan and/or delegate work to others
• Interacts with senior management from other RMD departments or Roche companies on significant matters often requiring coordination between departments/organziations

Clinical Research Finance Analyst Resume Examples & Samples

• Minimum of 1-3 years relevant work experience (Medicare Coverage Analysis, clinical trial budgeting, healthcare billing) (Required)
• Experience in an academic medical center, teaching hospital, or clinical research environment (Preferred)
• Working knowledge of federal and state laws, rules, and regulations related to research and healthcare billing (Required)
• Knowledge of FDA and Medicare regulations related to clinical trials (Required)
• Ability to interpret clinical research contracts, budgets, protocols, and consent forms (Required)
• Ability to effectively communicate at all levels (Required)
• Possess customer service skills appropriate for a fast-paced, high-volume, dynamic work environment (Required)
• Ability to prioritize a variety of diverse projects and their deadlines using exceptional time management skills (Required)
• Ability to work in a team environment and motivate team members by example (Required)
• Excellent verbal and written communications skills (Required)
• Ability to identify routine and/or unique problems and implement appropriate solutions (Required)
• Excellent interpersonal skills to effectively convey and explain information, influence outcomes and tactfully deal with diverse people, situations, and ideas (Required)
• Maintain confidentiality (Required)
• Operate with integrity and encourage trust (Required)
• Self-motivated (Required)
• Analytical (Required)
• Proficient in an automated environment, including effective utilization of Microsoft Windows (Outlook, Word, Excel, Power Point)
• Bachelor's Degree in Nursing preferred
• 2 years of experience in Nursing is required
• Previous experience in research nursing is required
• Join a stable team of CRAs across France and benefit from outstanding training and development, both initially and throughout your career
• Internal candidates
• Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP
• Technical experience and knowledge of Customer Relationship Management (CRM) tools and technology to organize, automate, and synchronize marketing and customer service is highly preferred
• Strong initiative and drive to develop and maintain innovative systems and techniques for participant recruitment
• Warm, engaging personal style, able to evoke excitement in others with regard to the mission of the

Manager Clinical Research Resume Examples & Samples

• 6~8 years of relevant experience in the field of research as a manager, administrator and/or investigator
• 3~5 years management experience leading diverse teams
• Oncology Research experience required
• Oncology Clinical experience preferred
• Knowledgeable of pertinent research federal and state regulatory guidelines
• Experience in conducting individual and small group education and training
• Experience in budgeting and negotiation and understanding of contracting language
• Demonstrated track record in managing research projects and funds from foundations, corporations and government sources
• Knowledge of Good Clinical Practices, International Conference on Harmonization Guidelines, FDA Guidance
• Strong knowledge of clinical trials and other types of clinical and translational research
• Travel to multiple Advocate Hospital sites and Corporate Headquarters for meetings required
• Abiltity to exert up to 50 pounds of force occasionally, and/or up to 30 pounds of force frequently, and/or up to 10 pounds of force constantly to move objects is required
• Walking. Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another is required
• Oversees day -to day operations and activities to support the start-up, conduct, and evaluation of clinical trial research activities of the center
• Oversees the interface between research staff and the Institutional Review Board and other Advocate offices to facilitate the conduct and compliance of clinical research
• Champions operational excellence by engaging in continuous improvement of processes, sharing of best practices, and participating in efforts to improve research within the center
• Assesses and provides education and training of research staff and investigators
• Partners to provide financial oversight related to research study project budgets
• Ensures regulatory compliance of research center
• Develops new business relationships to augment and advance the center and the Department of Research and Innovation
• Manages center communications related to research study availability, enrollment, and performance
• Electronic Chart Review
• Pre-screening potential patients
• Scheduling appointments
• EDC Data entry of key information regarding each candidate screened
• Community Outreach, visiting local businesses to raise awareness of study
• RN or LPN or Clinical research coordinator

Manager, Clinical Research Operations Resume Examples & Samples

• Establish, evaluate, and oversee clinical and administrative operations, regulatory compliance, policies and procedures training and education for the Office of Research Administration clinical operations division
• Manages and provides direction and leadership to clinical operations team
• Oversight and monitoring of all MHS clinical trials as it relates to the assigned campus
• Identify and communicate study-related issues. Facilitate and implement solutions with the research team
• Present significant research efforts, findings, outcomes, and approvals internally and to external audiences
• Utilize critical insight to evaluate and select research studies in conjunction with the Director of Clinical Operations and the associated Principal Investigator
• Lead new research initiatives by engaging other therapeutic area specialists to assess their areas of interest within clinical research
• Identify targets of opportunity both within the health system and with outside partners by exploring ways to integrate research opportunity within their practice area
• Provide general leadership in relation to each individual trial and effectively collaborate with other departments to meet all timelines and goals
• Independently oversees the functionality of study related documents such as Source Document Worksheets, Informed Consent Checklists, Concomitant Medication page etc
• Assure all aspects of research are compliant with regulatory and study standards
• Ensures timely follow up of industry research contracting execution (including Clinical Disclosure Agreement and Clinical Trial Agreement and Letter of agreements)
• Consideration of the financial integrity of all studies by overseeing the time and effort tracking for all staff involved in relation to each trial. Responsible for the oversight of clinical research billing. Conducts monthly study budget reviews with executive leadership, plans, and implements change
• Oversee research laboratory/pharmacy support services for Research Studies
• Fosters collaborative relationships with other departments, entities and community organizations to facilitate and support the mission, vision and goals of research
• Identifies and directly confronts issues which affect quality of service; collaborates with staff, manager and physicians to resolve these issues
• Utilizes collaborative communication techniques to achieve positive outcomes in all interactions
• Prepares accurate and timely written reports, statistics and other documentation as necessary or as requested
• Effectively manages change processes as they impact research operations and staff
• Maintains ongoing analysis of research performance and financial trends and opportunities
• Presents to work on time, follow organization rules, policies, procedures and directives
• Effectively interacts with staff in a positive and constructive manner
• Ability to make suggestions for enhancements throughout the department and continually seeks opportunities to improve current policies, procedures and practices while prioritizing the tasks assigned
• The Research Clinical Operations Manager must possess deep content expertise in leveraging Good Clinical Practice Guidelines to support clinical research operations as well as a proven track record of excellent leadership required for fostering effective collaboration between MHS executive leadership and research operations leadership
• 5 years of experience in a Clinical Research Operations, preferred
• Management and leadership experience in Clinical Research Operations, research or a related health care field
• Knowledge of research design, research process, study budgets and study implementation
• Strong leadership, planning and project management skills
• Thorough understanding of FDA, GCP and ICH guidelines
• Thorough understanding of research compliance requirements

Clinical Study Manager, Clinical Research Resume Examples & Samples

• *REMOTE BASED POSITION***
• Manage one or more clinical trials, including Investigational Device Exemption, post-approval, post-market surveillance, feasibility, and/or marketing studies
• Develop clinical plan strategies and execute on clinical study protocols, timelines, and budget management
• Collaborate with Clinical Operations Data Management on data collection, quality control and analysis of clinical trial patient data and radiographic results
• Support Regulatory and Marketing functions in strategic clinical data needs
• Communicate study results through annual reports, investigator meetings, and global clinical discussions; track study performance through metric-based results
• Demonstrate leadership qualities and mentor members of the Clinical Operations team
• Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures

Director, National Clinical Research Resume Examples & Samples

• Consistently exhibits behavior and communication skills that demonstrate DaVita Medical Group's commitment to superior customer service, including quality, care and concern with each and every internal and external customer
• Uses, protects, and discloses DaVita Medical Group patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards
• Add Job Functions for this Director Role
• Minimum: Over 7 years and up to including 10 years of management experience
• Interviewing and interpersonal skills

Asst-clinical Research Resume Examples & Samples

• Receives, answers and processes departmental communications, including mail, telephone calls, faxes and email
• Prepares reports, correspondence, presentations and other written documents as directed
• As directed, works with medical staff and residents in the collection of data for scholarly activity and quality control improvement. This may involve patient interviews, discussing projects with potential subjects and requesting consent, passing out and collecting surveys, chart review, and abstraction or participation in prospective research studies
• Performs/assists in transporting, processing, and storage of blood and body fluid specimens; packages specimens for shipping
• Uses the internet to search and obtain information as needed. Uses medical literature search engines to conduct literature reviews, and obtains requested journal articles. May read articles and write summaries
• Performs all other duties and projects as assigned
• 1 year of research experience preferred

Associate Clinical Research Operation Manager Resume Examples & Samples

• Accountable for all activities of site related study execution of assigned studies / Monitors involving start-up, execution, and close-out. Accountable for the on-time and within budget study execution of assigned projects, including but not limiting to country and site feasibility
• Oversee site evaluation/selection, contracts/budget negotiation, regulatory/EC submissions startup, issue management, relationship management, monitoring, and site closure. Provide local regulatory and legal requirement expertise
• Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Stay abreast of new and/or evolving local regulations, guidelines and policies. May monitor regulatory reforms and industry trends within country / district, and provide impact analysis of significant changes affecting conduct of Clinical studies
• Ensure audit and inspection readiness of assigned sites. Advise on pre-audit activities for GCP requirements. Prepare and follow up site and system audits, CAPA preparation and implementation
• Accountable for resource management for assigned team. Provide ongoing assessment and input towards resource needs and in allocating resources in alignment with AbbVie research goals, priorities, and specific study timelines. Proactively identify and communicate issues impacting resource allocation and provide solutions
• Responsible for the acquisition and retention, performance management, and growth and development of talent. May be responsible for being the country point of contact for CROs for an assigned study / studies. May participate/lead in global/local task forces and initiatives. Responsible for activities as assigned by manager
• If assigned; Independently serve as key point of contact in country/district for one or more studies with higher level complexity. Update Impact/Tesla with country-level information: Country-level planning timelines, LSR assignments, etc
• If assigned; Global Representative for single or multiple studies, collaborating with key stakeholders to achieve proactive, strategic and tactical success throughout the study planning, execution, and closeout phases leading to World Class clinical trials
• If assigned; Accountable for resource management and deliverables of the assigned Remote Data Review (RDR) team. Collaborate with key stakeholders to ensure appropriate study specific training and assignment of assigned staff to studies. Responsible for the direct/functional management, as applicable, of the assigned Remote Monitors including hiring, onboarding, training, task assignment, mentorship, performance management, and growth and development

Clinical Research LPN Translational Research Institute Orlando Resume Examples & Samples

• Ability to perform clinical tasks including assisting physician, ARNP and CRN with minor procedures and other study requirements as needed
• Ability to work independently and as a team under the direction of the Investigator, PM and Clinical Operations Manager
• Graduate of a nursing program
• One year of clinical or research experience
• Experience in the clinical/translational research environment (preferred)
• Computer skills, particularly Microsoft Outlook, Word, Excel, Publisher, PowerPoint, Cerner, use of internet and other research tools (preferred)
• Knowledge of clinical/translational research and research regulatory environment (preferred)
• Current active State of Florida license as an LPN or RN
• IV Certification, if LPN
• Current Basic Life Support (BLS) certification
• Current Advanced Cardiac Life Support (ACLS) certification (preferred)

Related Job Titles

Clinical Research Associate CV Example for 2024 (Skills & Templates)

Create a standout clinical research associate cv with our online platform. browse professional templates for all levels and specialties. land your dream role today.

Welcome to our Clinical Research Associate CV Example. Here, we will provide you with a comprehensive guide on how to create an effective CV for a Clinical Research Associate role. We will provide you with helpful tips and tricks, as well as advice on the best format and structure for your CV. With our help, you will be able to present your experience, qualifications, and skillset in a professional, concise manner, making you a prime candidate for the position.

We will cover:

• How to write a CV , no matter your industry or job title.
• What to put on a CV to stand out.
• The top skills employers from every industry want to see.
• How to build a CV fast with our professional CV Builder .
• What a CV template is, and why you should use it.

What does a Clinical Research Associate do?

A Clinical Research Associate (CRA) is responsible for monitoring and managing clinical research trials, ensuring that they are conducted in accordance with Good Clinical Practice, applicable regulations, and the study protocol. This includes activities such as site selection and qualification, initiation, monitoring, close-out and reporting of results. The CRA is responsible for making sure the trial is conducted ethically, safely, and in compliance with all relevant laws, regulations, and guidelines. They are usually the main contact between the research site and the sponsor, and they often supervise the activities of the research team at the site.

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What are some responsibilities of a Clinical Research Associate?

• Developing and managing study timelines and budgets
• Creating study protocols, case report forms, and informed consent forms
• Monitoring study sites to ensure compliance with protocol, Good Clinical Practice (GCP) guidelines, and applicable regulations
• Auditing study sites to check data accuracy and quality
• Reviewing data from study sites and ensuring data accuracy and completeness
• Providing guidance and training to study sites on protocol, GCP, and applicable regulations
• Ensuring that all safety reporting requirements are met
• Preparing data summaries and reports for review by project management
• Providing support for regulatory submissions and inspections
• Resolving queries and discrepancies with study sites

Sample Clinical Research Associate CV for Inspiration

Personal Details Name: Amy Smith Address: 123 Main Street, Los Angeles, CA, 90210 Phone: (310) 555-4567 Email: [email protected]

Summary Amy Smith is an experienced Clinical Research Associate with a strong background in clinical research operations, medical writing, and project management. She has a proven track record of successfully developing and managing clinical research studies from design to analysis. Amy has excellent communication skills and is highly organized, with a commitment to producing quality work on time and within budget.

Work Experience

• Clinical Research Associate, ABC Pharmaceuticals, Los Angeles, CA (2020 - Present)
• Manage clinical trials from design to analysis, including protocol development, data management, and study reporting.
• Conduct site visits and monitor clinical trial activities according to protocol and regulatory requirements.
• Prepare and review clinical documents, such as informed consent forms, trial protocols, and study reports.
• Clinical Research Coordinator, XYZ Research Center, Los Angeles, CA (2015 - 2020)
• Oversaw and coordinated clinical trials from design to completion.
• Initiated and maintained relationships with key stakeholders including investigators and clinical research sites.
• Reviewed and verified accuracy of clinical research data for accuracy and completeness.

Education Bachelor of Science in Nursing, University of California, Los Angeles, CA (2011 - 2015)

• Clinical research operations
• Medical writing
• Project management
• Data analysis
• Regulatory compliance

Certifications Certified Clinical Research Coordinator (CCRC)

Languages English (fluent), Spanish (conversational)

CV tips for Clinical Research Associate

Crafting an impeccable CV that kickstarts your career is a challenging endeavor. While adhering to fundamental writing principles is beneficial, seeking guidance customized for your unique job pursuit is equally prudent. As a newcomer to the professional realm, you require Clinical Research Associate CV pointers. We've curated top-notch advice from experienced Clinical Research Associate individuals. Explore their insights to streamline your writing journey and enhance the likelihood of fashioning a CV that captivates potential employers' attention.

• Highlight any relevant experience and qualifications in the field of clinical research.
• Detail your knowledge of clinical research protocols, regulations, and standards.
• List your experience with clinical trial design, data analysis, and data management.
• Mention any specialized certifications or training you have in the clinical research field.
• Include any specific accomplishments that demonstrate your ability to contribute to clinical research teams.

Clinical Research Associate CV Summary Examples

A Clinical Research Associate CV Summary or CV Objective gives potential employers a quick overview of your experience and skills. It can help to set you apart from other candidates by highlighting your qualifications and expertise in this specific field. It also gives employers a better idea of what you could bring to the role and how you could contribute to the company. A well-crafted CV Summary or Objective can help to give employers the confidence to call you in for an interview. For Example:

• Experienced Clinical Research Associate with 15 years of experience in the field. Demonstrated expertise in trial design and management, data analysis and reporting.
• Highly organized Clinical Research Associate with 10 years of experience in the clinical research industry. Proven ability to ensure compliance with regulatory standards.
• Detail-oriented Clinical Research Associate with 7 years of experience in the medical industry. Skilled at monitoring study progress, evaluating data and providing timely updates.
• Knowledgeable Clinical Research Associate with 5 years of experience in clinical trials. Experienced in developing clinical protocols, performing data collection and providing technical support.
• Dedicated Clinical Research Associate with 3 years of experience in the healthcare industry. Skilled at organizing and managing clinical trials, data analysis and reporting.

Build a Strong Experience Section for Your Clinical Research Associate CV

Building a strong experience section for a Clinical Research Associate (CRA) CV is essential for the success of a job search. A CRA is a specialized role in the healthcare industry and employers will want to see that the applicant has the relevant experience and skills needed for the role. The experience section will demonstrate the applicant’s ability to work independently and as part of a team, their knowledge of clinical research processes and protocols, and their compliance with industry standards. By highlighting their past accomplishments, the applicant can demonstrate their value to a potential employer. Additionally, a strong experience section will demonstrate the applicant’s ability to manage multiple tasks and show their commitment to the role. For Example:

• Planned and executed clinical trials and related activities to develop and validate medical devices.
• Conducted site visits to ensure compliance with clinical trial protocols.
• Prepared and reviewed study documents including clinical protocols, informed consent forms, and case report forms.
• Provided guidance and support to clinical sites regarding protocol requirements and implementation.
• Assisted in the development and implementation of clinical trial budgets.
• Monitored data collection and data entry to ensure accuracy and completeness.
• Reviewed and tracked adverse events and follow-up activities.
• Prepared clinical trial reports and presentations.
• Participated in the development of clinical study protocols and investigator brochures.
• Assisted in the preparation and review of regulatory submissions.

Clinical Research Associate CV education example

A Clinical Research Associate typically needs a bachelor's degree in a scientific field such as biology, chemistry, or nursing. Additional qualifications may include a master's degree in a related field and/or professional certification from a recognized organization such as the Association of Clinical Research Professionals (ACRP). Clinical Research Associates must also have good communication and organizational skills. Here is an example of an experience listing suitable for a Clinical Research Associate CV:

• Bachelor of Science in Biology, University of California, Los Angeles, CA (2012-2016)
• Master of Science in Clinical Research, University of Southern California, Los Angeles, CA (2017-2019)
• Certificate of Clinical Research Associate, Academy of Clinical Research Professionals, Los Angeles, CA (2019)

Clinical Research Associate Skills for a CV

Adding skills to your Clinical Research Associate CV is important because it helps to demonstrate to potential employers the abilities and qualities you possess that are relevant to the position you are applying for. Skills can include areas such as communication, data analysis, problem solving, regulatory compliance, report writing, time management, and more. By showcasing these skills, employers can see that you are capable of meeting the demands of the job and will be able to bring value to their organization. Soft Skills:

• Communication
• Organizational
• Problem-solving
• Interpersonal
• Time-management
• Adaptability
• Project Management
• Data Analysis
• Clinical Trials
• Regulatory Compliance
• Study Planning
• Protocol Writing
• Clinical Monitoring
• Problem Solving
• Time Management
• Research Skills

Common Mistakes to Avoid When Writing a Clinical Research Associate CV

In today's competitive job market, an average of 180 applications floods employers' inboxes for each vacant position. To streamline this influx of CVs, companies frequently employ automated applicant tracking systems that weed out less qualified candidates. If your CV manages to surpass these digital gatekeepers, it must still captivate the attention of the recruiter or hiring manager. Given the sheer volume of applications, a mere 5 seconds is typically allocated to each CV before a decision is reached. With this in mind, it's crucial to eliminate any extraneous information that might relegate your application to the discard pile. To ensure your CV shines, consult the list below for elements to avoid including in your job application.

• Skipping the cover letter: A well-crafted cover letter is an opportunity to showcase your suitability for the role and express your enthusiasm for it.
• Excessive jargon: CVs laden with technical terms can alienate hiring managers who lack specialized knowledge.
• Neglecting vital details: Incorporate your contact information, education, work history, and pertinent skills and experiences.
• Relying on generic templates: Tailoring your CV to the specific job exhibits your commitment to the position and company.
• Errors in spelling and grammar: Proofreading is essential to eliminate typos, spelling errors, and grammatical blunders.
• Overemphasizing duties: Highlight accomplishments to underline your candidacy's value.
• Sharing personal information: Steer clear of revealing personal details like age, marital status, or religious affiliations.

Key takeaways for a Clinical Research Associate CV

• Include a professional summary that highlights your experience and qualifications.
• List your education and certifications related to clinical research.
• Highlight any relevant research projects you have been involved in.
• Detail the types of clinical research studies you have been involved in.
• Outline any additional skills or knowledge you have acquired.
• Provide examples of any awards or recognition you have received.
• Include any additional professional development activities you have taken part in.

• • Managed a portfolio of 5+ clinical trials, focusing on cardiology, improving patient enrollment by 25% through strategic outreach and communication
• • Accelerated data collection and trial efficiency by implementing a new EDC system, resulting in a 20% reduction in data entry errors over a six-month period
• • Conducted comprehensive chart reviews and patient interviews, identifying key patterns that contributed to a 10% optimization in treatment protocols
• • Led a team of research assistants, enhancing team productivity by organizing quarterly skill-building workshops and fostering a collaborative environment
• • Generated detailed reports and presented findings at 3 international conferences, effectively communicating insights to the broader medical research community
• • Developed strong partnerships with industry sponsors and stakeholders, securing additional funding for two major research projects
• • Orchestrated the data management for multiple studies in oncology, resulting in high-fidelity datasets that supported robust statistical analysis
• • Delivered consistent subject-related activities for over 100 participants by enforcing rigorous ethical and confidentiality standards
• • Created and maintained a database for a longitudinal study, enhancing data accuracy and participant tracking efficiency by 30%
• • Assisted with regulatory documentation, achieving 100% compliance with IRB standards across all managed studies
• • Facilitated inter-departmental collaborations that improved research project timelines by facilitating streamlined communication
• • Contributed to a pioneering study on diabetes management that influenced the adoption of new dietary guidelines for patients
• • Assisted in the recruitment and screening process, boosting enrollment by 40% through community engagement initiatives
• • Streamlined data entry processes by integrating a mobile data collection platform, minimizing errors and saving time
• • Supported senior researchers with bench work and data analysis, which played a critical role in two publications

5 Research Associate Resume Examples & Guide for 2024

Research Associates play a crucial role in supporting research projects by collecting data, analyzing results, and contributing to reports. Highlighting your experience with data analysis, project management, and collaboration on your resume can set you apart from other candidates. Consider emphasizing proficiency in statistical software, strong communication abilities, and attention to detail, as these are highly valued in the field. Additionally, mentioning successful projects you've contributed to and any publications or presentations can effectively demonstrate your contributions and impact in research settings.

All resume examples in this guide

Traditional

Resume Guide

Resume Format Tips

Resume Experience

Skills on Resume

Education & Certifications

Resume Summary Tips

Additional Resume Sections

Key Takeaways

As a research associate, articulating the complexity of your research projects in a concise manner on your resume can be a daunting challenge. Our guide provides you with clear examples and strategies to succinctly showcase your scholarly endeavors without oversimplifying your valuable contributions.

• Which sections do you need to include in your resume to meet recruiters' requirements;
• How to write your research associate resume experience section - even if you have don't have little to no work experience;
• Real-life professional examples to guide you how to write the most important research associate resume sections;
• Adding even more sections so your research associate resume stands out with professionalism and your personality.

We've also selected some of the best (and most relevant) resume guides for the research associate role you're applying for:

• Research Manager Resume Example
• Research Assistant Resume Example
• Researcher Resume Example
• Lab Technician Resume Example
• Scientist Resume Example
• Radiologic Technologist Resume Example
• Chemist Resume Example
• Research Director Resume Example
• Lab Assistant Resume Example
• Lab Manager Resume Example

Formatting the layout of your research associate resume: design, length, and more

• If you have plenty of experience, you'd like to showcase, invest in the reverse-chronological resume format . This format focuses on your latest experience items and skills you've learned during your relevant (and recent) jobs.
• Don't go over the two-page limit, when creating your professional research associate resume. Curate within it mainly experience and skills that are relevant to the job.
• Make sure your research associate resume header includes all of your valid contact information. You could also opt to display your professional portfolio or LinkedIn profile.
• Submit or send out your research associate resume as a PDF, so you won't lose its layout and design.

Upload & Check Your Resume

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The more time and effort you've put into obtaining the relevant certificate, the closer to the top it should be listed. This is especially important for more senior roles and if the company you're applying for is more forward-facing.

The five (plus) definite sections your resume for a research associate job should include are:

• Header with your headline, contact details, and/or a preview of your work
• Summary (or objective) to pinpoint how your success aligns with the role
• Experience with bullets of your most relevant achievements in the field
• Skills to integrate vital job requirements (both technical and personal)
• Your further dedication to the field, showcased via relevant higher education and/or certifications

What recruiters want to see on your resume:

• Relevant research experience and technical skills, such as data analysis, laboratory techniques, or subject matter expertise.
• Strong analytical skills demonstrated through previous research projects or publications.
• Proficiency with relevant research tools and software, like statistical software packages (e.g., SPSS, R, SAS) or laboratory equipment.
• Evidence of problem-solving abilities and critical thinking skills, essential for developing research methodologies and troubleshooting experiments.
• Communication skills, including the ability to clearly articulate findings in written reports and present research results effectively to diverse audiences.

Experts' advice on writing your research associate resume experience

While the excitement and motivation for writing your research associate resume was present in the first hour (or so), you now find yourself staring at the blank page.

The resume experience section is the one that allows you to make a memorable impression by matching job requirement with your past jobs and accomplishments.

To help you write this resume section, here are four mistakes you need to avoid:

• Listing every job you have had so far, including the irrelevant ones. Before that, consider each of your past roles based on relevancy to the role. It may be the case that the job you had 15 years ago may have taught you invaluable skills that are appropriate for the role;
• Including irrelevant work experience items . Those are past jobs that aren't linked with the role you're applying for (or so they seem). Consider how your past jobs will serve your professional presentation: will they be filling in a gap in your work history, or just taking up space?
• Focusing on responsibilities instead of accomplishments. Your research associate resume shouldn't just be telling recruiters what you did in the past - as it's most often the case that candidates have had similar responsibilities. But, rather, the experience section should showcase the success you've attained in each past role, thanks to your unique skill set;
• Consider listing just your professional experience. Any role you've had in the past - e.g. volunteering, internships, etc. - can make it into your research associate resume experience section. Make sure to include it alongside numbers and results.

Two more things you need to remember about your resume experience section.

The first are keywords. Or those specific job requirements that are crucial for the role . Ensure you've integrated them across your experience section to get sorted closer to the ideal candidate profile by the Applicant Tracker System (ATS).

The second are action verbs. Each of your experience bullets should start with a strong action verb , followed by your specific skill and your on the job achievements. Follow this formula to hint to recruiters what your unique value as a professional is.

Still with us? In the next section, we will show you how industry-leading professionals have avoided the four most common mistakes, while integrating keywords and action verbs in their experience section.

• Initiated and successfully completed a 3-year longitudinal study on the effects of environmental variables on crop yield, increasing understanding of sustainable agricultural practices.
• Collaborated with cross-functional teams to analyze over 10,000 data points, improving data integrity by 25% through meticulous quality control protocols.
• Authored and co-authored 5 peer-reviewed publications on research findings, enhancing the company's academic reputation and contributing to scientific discourse.
• Oversaw a team of 4 research assistants, coordinating research on gene therapy techniques which fast-tracked the development of two potential treatments.
• Managed a budget of $500,000 for a high-profile project investigating autoimmune diseases, coming under budget by 10% through efficient resource allocation.
• Established a partnership with a leading university, securing access to advanced research equipment and intellectual collaboration for our team.
• Designed and executed a novel viral vector study, contributing to a 15% reduction in development time for targeted gene therapy applications.
• Presented research findings at 3 major international conferences, raising the profile of the company within the scientific community.
• Developed a proprietary method for cell line development, which has since become a standard protocol within the team.
• Played a key role in a breakthrough research study on Alzheimer’s disease, contributing to a potential treatment path that is currently in phase II clinical trials.
• Mentored 2 junior research associates, supporting their professional development and enhancing research team throughput by 30%.
• Implemented an automated data analysis system which cut down analysis time by 40%, allowing the team to accelerate the research pipeline.
• Leading a pivotal study in the development of a new class of immunotherapies, with early results indicating a 20% increase in efficacy over existing treatments.
• Coordinating with clinical operations to ensure seamless integration of bench research findings with ongoing clinical trials.
• Enhancing lab group productivity by implementing a cloud-based data management system, which has reduced data retrieval times by 50%.
• Contributed to a significant drug discovery project that led to the identification of a novel kinase inhibitor prototype.
• Delivered comprehensive support in the patent application process for three novel chemical entities discovered by the team.
• Coordinated the establishment of a new laboratory, including equipment procurement and SOP development, within a tight 6-month deadline.
• Instrumental in the development of a new analytical technique that improved detection of biomarkers by 40%, which has since been adopted industry-wide.
• Managed the collection and secure transportation of over 5,000 unique biological samples adhering to international research guidelines.
• Facilitated a series of workshops and seminars on advanced genomics techniques, reaching over 100 industry professionals.
• Designed a pioneering study in the field of CRISPR technology, contributing to a groundbreaking method of gene editing that could revolutionize genetic disease treatment.
• Effectively managed laboratory resources to ensure ongoing supply availability, never exceeding budget and often saving costs by negotiating better rates with suppliers.
• Established a comprehensive database for genetic sequencing results, directly enhancing the speed and accuracy of data retrieval for ongoing research efforts.
• Implemented a novel sample preparation protocol, reducing sample degradation by 35% and significantly improving the reliability of downstream analyses.
• Led a successful quality improvement initiative for laboratory processes, achieving a 20% increase in operational efficiency.
• Spearheaded the development of a therapeutic protein that has shown promise in pre-clinical studies for treating rare genetic disorders.
• Engaged in a highly complex research project that mapped out the epigenetic landscape of several cancers, providing valuable insights for the development of targeted therapies.
• Developed a strong collaborative network with leading academic institutions to synergize research efforts in oncology.
• Streamlined data collection workflows, which resulted in a consistent 5-10% reduction in time-to-completion for research project milestones.

Quantifying impact on your resume

• Detail the number of research projects managed or contributed to, demonstrating project management skills and expertise.
• Specify the percentage of efficiency improvement in data collection or analysis processes you initiated or optimized.
• Include the total amount of funding received from grants or scholarships, highlighting your ability to secure financial resources.
• Quantify the number of published articles or presentations given, showcasing your communication and knowledge dissemination capabilities.
• State the size of the datasets you have worked with to demonstrate your capacity for handling complex data.
• Mention the number of interdepartmental collaborations you participated in, reflecting teamwork and interdisciplinary skills.
• Describe your role in increasing the accuracy or reliability of results by a certain percentage, emphasizing your attention to detail and quality of work.
• Report any cost reductions achieved through your research initiatives, showing your contribution to the financial health of the organization.

Action verbs for your research associate resume

What can candidates do about their resume, if they have no experience

Job requirements can sometimes be answered by other elements you could make more prominent in your research associate resume.

Thus, you'd be substituting your lack of experience with your relevant:

• Education with details of skills you've obtained that align with the job
• Internships and short-term jobs that are once more dedicated to putting your expertise in the spotlight
• Skills section answering basic and - potentially - more specific job qualifications
• Strengths or accomplishments to show the unique value you present, even as a candidate with less or no professional experience in the industry.

Recommended reads:

• Perfecting the Education Section on Your Resume
• How To List Certifications On A Resume (Examples Included)

List your educational qualifications and certifications in reverse chronological order.

Popular research associate hard skills and soft skills for your resume

Apart from assessing your professional expertise, recruiters are on the lookout for whether your skills align with the job.

Your profile would thus be assessed in regard to your:

• Hard or technical skills - your ability to perform on the job using particular technologies or software
• Soft skills - how you adapt, communicate, and thrive in different environments.

Both types of skills - hard and soft skills - are important for your resume, so make sure to create a dedicated skills section that:

• Lists up to five or six skills that align with the job advert.
• Integrates vital keywords for the industry, but also reflects on your personal strengths.
• Builds up further your skills with an achievements section within which you explain what you've achieved thanks to using the particular skill.
• Aims to always quantify in some way how you've used the skill, as it's not enough to just list it.

What are the most sought out hard and soft skills for research associate roles?

Check out the industry's top choices with our two dedicated lists below:

Top skills for your Research Associate resume:

Statistical Analysis Software (SAS)

R Programming

Microsoft Excel

Data Visualization Tools (e.g., Tableau, Power BI)

Qualitative and Quantitative Research Methods

Survey Design and Analysis

Database Management (SQL)

Literature Review Techniques

Laboratory Techniques (if applicable)

Critical Thinking

Attention to Detail

Communication Skills

Time Management

Collaboration

Problem-Solving

Adaptability

Organizational Skills

Project Management

List all your relevant higher education degrees within your resume in reverse chronological order (starting with the latest). There are cases when your PhD in a particular field could help you stand apart from other candidates.

Research Associate-specific certifications and education for your resume

Place emphasis on your resume education section . It can suggest a plethora of skills and experiences that are apt for the role.

• Feature only higher-level qualifications, with details about the institution and tenure.
• If your degree is in progress, state your projected graduation date.
• Think about excluding degrees that don't fit the job's context.
• Elaborate on your education if it accentuates your accomplishments in a research-driven setting.

On the other hand, showcasing your unique and applicable industry know-how can be a literal walk in the park, even if you don't have a lot of work experience.

Include your accreditation in the certification and education sections as so:

• Important industry certificates should be listed towards the top of your resume in a separate section
• If your accreditation is really noteworthy, you could include it in the top one-third of your resume following your name or in the header, summary, or objective
• Potentially include details about your certificates or degrees (within the description) to show further alignment to the role with the skills you've attained
• The more recent your professional certificate is, the more prominence it should have within your certification sections. This shows recruiters you have recent knowledge and expertise

At the end of the day, both the education and certification sections hint at the initial and continuous progress you've made in the field.

And, honestly - that's important for any company.

Below, discover some of the most recent and popular Research Associate certificates to make your resume even more prominent in the applicant pool:

The top 5 certifications for your research associate resume:

• Certified Research Associate (CRA) - Association of Clinical Research Professionals (ACRP)
• Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SoCRA)
• Project Management Professional (PMP) - Project Management Institute (PMI)
• Good Clinical Practice (GCP) Certification - various accredited institutions
• Biotechnology Project Management Specialization (BPMS) - Biotechnology Innovation Organization (BIO)

If you happen to have plenty of certificates, select the ones that are most applicable and sought-after across the industry. Organize them by relevance to the role you're applying for.

• How To Include Your Relevant Coursework On A Resume

Writing the research associate resume summary or objective: achievements, keywords, dreams, and more

Deciding on whether to include a resume summary or resume objective should entirely depend on your career situation.

If you have:

• Plenty of relevant achievements you'd like to bring recruiters' focus to, make use of the resume summary. Ensure each of your achievements is quantified with concrete proof (e.g. % of cases solved).
• Less applicable experience, utilize the resume objective. Within the objective include a few noteworthy, past successes, followed up by your professional dreams.

As a bonus, you could define in either your research associate resume summary or objective what makes you the perfect candidate for the role.

Think about your unique hard and soft skills that would make your expertise even more important to the job.

These research associate professionals have completely covered the formula for the ideal resume introduction:

Resume summaries for a research associate job

• Dedicated Research Associate with over 7 years of experience in biomedical laboratory environments, skilled in advanced molecular biology techniques, and a track record of publishing findings in respected journals. Spearheaded a major study on gene expression that contributed to the development of novel therapeutic strategies.
• Seasoned professional with a decade of experience in analytical chemistry, transitioning to biological research to leverage strong background in data analysis and experiment design. Acknowledged for identifying key chemical markers leading to the improvement of industry-standard detection methods.
• Highly motivated individual with 5 years of experience in data-driven environmental research, eager to apply quantitative analysis and project management skills to clinical studies. Notable accomplishment includes leading an award-winning research project on climate change effects on marine ecosystems.
• Experienced financial analyst with a Master's degree in Bioinformatics looking to apply quantitative skills to genetic research. Recognized for developing a predictive model that notably increased investment returns by 20% year-on-year, seeking to contribute to groundbreaking genetic research.
• Aspiring Research Associate stepping into the professional world of scientific inquiry, keen to apply a fresh outlook and robust academic foundation from a Master's in Microbiology. Determined to assist in cutting-edge research and eager to develop specialized skills within a dynamic lab setting.
• Recent biology graduate aiming to leverage strong analytical skills, a passion for genetic research, and an educational background that includes hands-on laboratory experience. Enthusiastic about contributing to meaningful research that advances understanding in the field of genomics and molecular biology.

Taking your research associate resume to the next level with these four additional resume sections

Your research associate resume can feature a variety of skills (both hard and soft) in diverse sections . Choose those that align best with the job requirements and reflect your suitability for the company culture.

Consider these four additional resume sections recommended by our experts:

• Languages - State any languages you are proficient in and your level of proficiency. This demonstrates your commitment to communication and potential for international growth.
• Projects - Highlight up to three significant projects you've completed outside of work, showcasing skill development. Include a link to your project portfolio in the research associate resume header, if applicable.
• My Time - How you allocate your time outside work can indicate your organizational skills and cultural fit within the company.
• Volunteering - Detail causes you're passionate about, roles you've held, and achievements in volunteering. Such experiences likely have honed a range of soft skills crucial for your dream job.

Key takeaways

Securing your ideal job starts with crafting a compelling research associate resume. It should not only highlight your professional strengths but also reflect your personality. Key aspects to remember include:

• Choose a clear, easily editable format, allowing more time to focus on the content of your resume;
• Emphasize experience relevant to the job, focusing on your impact on the team;
• Opt for a resume summary if you have extensive professional experience, and a resume objective if you're just starting out;
• Include technical skills in the skills section and interpersonal skills in the achievements section;
• Recognize the importance of various resume sections (e.g., My Time, Projects) in showcasing both your professional abilities and personal traits.

Looking to build your own Research Associate resume?

• Resume Examples

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Resume Worded   |  Resume Skills

Skill profile, clinical research associate, improve your resume's success rate by using these clinical research associate skills and keywords ..

• Hard Skills and Keywords for your Clinical Research Associate Resume
• ATS Scan : Compare Your Resume To These Skills
• Sample Resume Templates
• How To Add Skills
• Clinical Research Associate More Resume Templates

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Frequently asked questions.

• 3. Effective Action Verbs for your Resume

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Looking for keywords for a specific job search for your job title here., © 2024 resume worded. all rights reserved., clinical research associate resume keywords and skills (hard skills).

Here are the keywords and skills that appear most frequently on recent Clinical Research Associate job postings. In other words, these are the most sought after skills by recruiters and hiring managers. Go to Sample Templates ↓ below to see how to include them on your resume. Remember that every job is different. Instead of including all keywords on your resume, identify those that are most relevant to the job you're applying to. Use the free Targeted Resume tool to help with this.

• Good Clinical Practice (GCP)
• Clinical Monitoring
• Clinical Trial Management System (CTMS)
• Electronic Data Capture (EDC)
• Clinical Trials
• Clinical Research
•  Find out what your resume's missing
• Clinical Development
• CRO Management
• Clinical Research Associates
• Clinical Data Management
• Standard Operating Procedure (SOP)
• Therapeutic Areas
• Clinical Operations
• Oncology Clinical Research
• Regulatory Submissions
• U.S. Food and Drug Administration (FDA)
• Clinical Site Monitoring
• Biotechnology

Resume Skills: Regulations

• ICH Guidelines
• FDA Regulations
• Health Insurance Portability and Accountability Act (HIPAA)
• FDA regulations
• ICH guidelines
• Code of Federal Regulations Title 21
•  Match your resume to these skills

Resume Skills: Languages

• Spanish (Fluent)

Resume Skills: Software

• Oracle Clinical
• Medidata Rave
• Microsoft Office Suite (Excel, PowerPoint, Word)
• MS Office Suite
• ClinCapture
• OpenClinica
• EDC Systems
• Clinical Conductor
• Electronic Data Capture (EDC) Systems
• Statistical Software (SAS, SPSS)
• Microsoft Office
• Clinical Data Management System (CDMS)
• Biostatistics

Resume Skills: Technical

• Clinical Trial Data Reporting
• Electronic Health Records (EHR)
• Python for Data Analysis
• Clinical Data Management Systems (CDMS)

Resume Skills: Regulatory Knowledge

• ICH-GCP guidelines
• Clinical research ethics
• FDA guidelines
• Clinical Study Reports

Resume Skills: Project Management

• Stakeholder Management
• Risk Management
• Agile and Scrum methodologies
• Risk Assessment
• Contract Negotiation
• Time Management
• Decision Making

Resume Skills: Clinical Research

• Clinical Trial Design
• Regulations Compliance
• Scientific Writing
• Designing and Conducting Clinical Trials
• Regulatory Compliance
• Patient Recruitment
• Data Analysis
• Site Monitoring
• Report Writing
• Clinical Trials Management
• Drug Development Process
• Data Collection and Analysis
• Protocol Development
• Data Management
• Adverse Event Reporting
• Clinical Trial Protocols
• IRB Submissions
• Clinical Trial Monitoring
• Ethics in Clinical Research
• Clinical Trial Designs
• Data Collection & Analysis
• Clinical Trial Management
• Phase I-IV Trials
• Clinical Study Design
• Protocol development
• Clinical monitoring
• Regulatory compliance
• Data collection and analysis
• Quality Assurance

Resume Skills: Biomedical Techniques

• Molecular Biology Techniques
• Cell Culture
• Bioinformatics

Resume Skills: Technologies and Tools

• Medical Imaging Software

Resume Skills: Data Analysis & Statistics

• Python (Pandas, Numpy)
• Epidemiology

Resume Skills: Medical

• Medical Terminology
• Patient Care
• Medical Specimen Collection
• Microbiology Techniques

Resume Skills: Communication & Documentation

• Medical Reporting
• Protocol Writing
• Patient informed Consent forms
• Medical Review
• Medical Documentation

Resume Skills: Regulatory & Quality Assurance

• FDA Regulatory Guidelines
• Good Clinical Practices
• ICMJE Recommendations
• EMA Guidelines

Resume Skills: Regulation and Compliance

• Ethical Guidelines

  Where on my resume do I add these buzzwords? Add keywords directly into your resume's work experiences , education or projects. Alternatively, you can also include a Skills section where you can list your technical skills in order of your proficiency. Only include these technical skills or keywords into your resume if you actually have experience with them.

   Does your resume contain all the right skills? Paste in your resume in the AI Resume Scan ↓ section below and get an instant score.

Compare Your Resume To These Clinical Research Associate Skills (ATS Scan)

Paste your resume below and our AI will identify which keywords are missing from your resume from the list above (and what you need to include). Including the right keywords will help you get past Applicant Tracking Systems (i.e. resume screeners) which may scan your resume for keywords to see if you're a match for the job.

Sample Clinical Research Associate Resume Examples: How To Include These Skills

Add keywords directly into your resume's work experiences , education or skills section , like we've shown in the examples below. use the examples below as inspiration..

  Where on my resume do I add these buzzwords? Add keywords directly into your resume's work experiences , education or projects. Only include these technical skills or keywords into your resume if you actually have experience with them.

How do I add skills to a Clinical Research Associate resume?

Go through the Clinical Research Associate posting you're applying to, and identify hard skills the company is looking for. For example, skills like Electronic Data Capture (EDC), Good Clinical Practice (GCP) and Clinical Development are possible skills. These are skills you should try to include on your resume.

Add other common skills from your industry - such as Clinical Research, Clinical Trial Management System (CTMS) and Clinical Monitoring - into your resume if they're relevant.

Incorporate skills - like Clinical Research Associates, Oncology Clinical Research and Clinical Site Monitoring - into your work experience too. This shows hiring managers that you have practical experience with these tools, techniques and skills.

Consider including a section in your resume dedicated to your research experience. On Clinical Research Associate resumes, hiring managers want to see research projects which you led or where involved with, and their outcomes.

Try to add the exact job title, Clinical Research Associate, somewhere into your resume to get past resume screeners. See the infographic for how to do this.

Word Cloud for Clinical Research Associate Skills & Keywords

The following word cloud highlights the most popular keywords that appear on Clinical Research Associate job descriptions. The bigger the word, the more frequently it shows up on employer's job postings. If you have experience with these keywords, include them on your resume.

Get your Resume Instantly Checked, For Free

Upload your resume and we'll spot the issues in it before an actual clinical research associate recruiter sees it. for free., clinical research associate resume templates.

Here are examples of proven resumes in related jobs and industries, approved by experienced hiring managers. Use them as inspiration when you're writing your own resume. You can even download and edit the resume template in Google Docs.

Resume Example Operations Associate (Entry Level Operations Manager)

An effective Description of the templates...

Download this resume template

Operations associates can learn about business operations as they work to support the day-to-day functioning of a company. While you do need to be organized and conscientious for this type of role, you don’t need management experience for this entry-level role -- so use your resume to underscore your education and internship history, as shown in this resume.

Tips on why this template works

   leads with educational experience.

As an entry-level applicant, you won’t have a lot of work history to discuss -- so start your resume off with what you have accomplished in school and internship experience. If you’ve done coursework in relevant areas such as data analytics or operating systems, it’s great to mention that up-front.

   Relevant internship experience

This resume points out accomplishments at internships that directly relate to being an operations associate. The bullet points show that even though you’re early in your career, you’ve already made an impact with your work.

Resume Example Sales Associate / Retail Salesperson

A retail sales associate, typically a sales associate working specifically in a brick-and-mortar store, must have excellent interpersonal skills and the emotional intelligence to interact with a variety of different customers daily. When crafting your retail sales associate resume, make sure to emphasize the relevant skills and experience you have developed in your past retail roles.

   Tailored retail work experience

Retail sales involves extensive face-to-face interaction with customers on a daily basis, and hiring managers are looking for candidates who can effectively handle the unique challenges that come up in this environment. Make sure to include as much relevant experience you have for the role -- even outside of just retail. For example, if you worked as a receptionist, you were often working face-to-face with an office’s clients. If you think outside the box like this, you can probably come up with more relevant experiences than you realize!

   Relevant skills in retail and sales

Focus on including retail-oriented skills in your skills section. Showing hiring managers that you have applicable experience in working a cash register, improving operations, or troubleshooting credit card issues can be the difference between landing a job or getting passed over. In addition, make sure you read through the job posting to see what skills they list, and emphasize the skills they’ve highlighted throughout your resume.

Resume Example Clinical Research Assistant

Clinical research assistants work on clinical trials in hospitals and medical research centers. As a clinical research assistant, you’ll be assisting doctors and senior researchers by recruiting and enrolling research subjects, developing protocols, setting up and managing trials, collecting and analyzing data, and contributing to trial reports, regulatory authority applications, and grant writing. Ideally, you’ll need some experience or a degree in the field of study and clinical trial experience.

   Focused on clinical research

When applying for a more specialized position like clinical research assistant, you want to keep your resume as tightly focused as possible. That means prioritizing clinical research experience. It’s fine to include general research experience, but try to tailor your bullet points by including accomplishments relevant to clinical research, like preparing regulatory documents and conducting medical research.

   Good use of skills section to highlight research skills and tools

Jobs that require a lot of hard skills, like clinical research, may end up with a larger than usual skills section. Avoid making recruiters’ eyes glaze over by splitting it into subsections, like certifications, techniques, and technical skills. Make sure you’re exclusively listing hard skills — employers want to see things like relevant software skills and clinical trial experience.

Resume Example Laboratory Research Assistant

As a laboratory research assistant, you’ll be working in a laboratory environment to design projects, conduct research and experiments, write reports, perform general laboratory maintenance, and assist senior laboratory staff — so make sure to emphasize your technical skills. You may be working for a private laboratory, medical or research facility, or pharmaceutical company. Unlike standard research assistant positions, lab assistants typically work full-time, including weekend and evening shifts.

   Bullet points feature strong action verbs

Every bullet point should start with a strong action verb. Remember, your resume is supposed to highlight your accomplishments, not simply list your job duties. As a laboratory research assistant, you’ll want to emphasize your scientific expertise. Verbs like Researched, Designed, and Developed all reflect the skills you’ll be expected to use on the job.

   Uses hard numbers and metrics

Including metrics in your bullet points is the best way to demonstrate the outcome of your work. This doesn’t mean every bullet point needs to include numbers but try to quantify your accomplishments whenever possible. If you analyzed data with 98% accuracy, reduced processing times by 25%, or performed research on 1,000 subjects, say exactly that.

Resume Example Graduate Research Assistant

Graduate research assistants are able to work while they study, receiving a tuition reimbursement or stipend as well as valuable experience working in academia. As a graduate research assistant, you’ll have completed an undergraduate degree and be pursuing a master’s degree or PhD. You’ll generally be working closely with a supervisor to support their projects, including conducting research, analyzing data, writing reports, and supervising undergraduate research assistants.

   Highlights university research projects

As a graduate research assistant, hiring managers won’t expect you to have extensive paid experience. If you’ve worked on previous research projects as a student, you can list these under your work experience or in an education or projects section. For greater impact, use action verbs and metrics to frame your accomplishments in an action-focused way.

   Includes a resume summary focused on graduate research interests and experience

Even as a graduate, you may have significant research experience, especially if you’ve been heavily involved in student research. You can highlight your skills and background with a short resume summary — no more than 100 words — explaining your years of experience, research or educational specialization, and 1-2 of your most impressive accomplishments.

Resume Example Chemistry Research Student

When applying to be a chemistry research student assistant, emphasize your past research experience and chemistry skills in your resume. Chemistry is a specific and precise discipline, and your resume should reflect these qualities. Aim to choose instances that detail your expertise in hands-on lab procedures or with relevant software, as opposed to simply listing out the responsibilities you were assigned. Use strong action verbs and be deliberate with what you include.

   Emphasize hard skills with metrics relevant to chemistry

As mentioned above, chemistry is a precise discipline -- you’re often working in the lab with dangerous chemicals or complex equipment. That means that the employers reading your resume -- labs, government agencies, or academic institutions -- are looking for evidence of your experience and skills in those areas. Do your research to find what types of software the job posting notes, whether that’s MATLAB, Solidworks, or ANSYS. Emphasize the hard skills you’ve learned through your past experience with powerful action verbs, and highlight your achievements with quantifiable metrics.

   Concise, informational chemistry resume summary

This resume makes great use of a concise, information-packed elevator pitch that is well-written and to the point. Chemistry recruiting managers often don’t have time to carefully read through every detail of your resume, so a resume summary is a great way for them to get a high-level overview of your work history. When brainstorming what to put in your chemistry resume elevator pitch, include your personal strengths as a chemist, or even the types of people you’ve learned to work with (i.e., biostatisticians, pathologists, professors).

What are the top skills you should add to your Clinical Research Associate resume?

On top Clinical Research Associate resumes, skills like Good Clinical Practice (GCP), Clinical Monitoring, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Clinical Trials, Clinical Research, Protocol and Clinical Development appear most often. Depending on the exact role you're applying to, skills like Clinical Research Associates, Regulatory Submissions, Clinical Site Monitoring, Oncology Clinical Research and CRO Management can also be effective keywords to include on your resume.

Target your Resume to a Job Description

While the keywords above are a good indication of what skills you need on your resume, you should try to find additional keywords that are specific to the job. To do this, use the free Targeted Resume tool. It analyzes the job you are applying to and finds the most important keywords you need on your resume. It is personalized to your resume, and is the best way to ensure your resume will pass the automated resume filters. Start targeting your resume

Most resumes get auto-rejected because of small, simple errors. These errors are easy to miss but can be costly in your job search. If you want to make sure your resume is error-free, upload it to Score My Resume for a free resume review. You'll get a score so you know where your resume stands, as well as actionable feedback to improve it. Get a free resume review

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Find out what keywords recruiters search for. These keywords will help you beat resume screeners (i.e. the Applicant Tracking System).

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6 Research Scientist Resume Examples and Templates for Your Successful 2024’s Job Search

Our Resumes are featured in

• • Led a project to optimize the lab's data analysis workflow, reducing processing time by 40% and resulting in $50,000 annual savings.
• • Collaborated with a team of 10 researchers to design and implement a novel research protocol, leading to a 15% increase in data accuracy.
• • Managed a database of over 20,000 research entries, ensuring data integrity and quick access to crucial information for ongoing projects.
• • Authored and co-authored 5 peer-reviewed research papers, with one being cited over 50 times within the first year of publication.
• • Trained and mentored junior researchers and graduate students, creating training materials and leading workshops resulting in enhanced lab productivity.
• • Facilitated cross-departmental collaborations, contributing to 3 groundbreaking multidisciplinary research projects recognized at national conferences.
• • Assisted in the development and validation of a new diagnostic assay, improving test reliability by 25%.
• • Conducted extensive literature reviews, summarizing findings in comprehensive reports that guided strategic research directions.
• • Analyzed large datasets using advanced statistical tools, contributing to the publication of 3 research papers.
• • Presented research findings at weekly lab meetings, fostering an environment of continuous learning and feedback.
• • Implemented standardized operating procedures for lab equipment, reducing operational errors by 15%.

Research Scientists map the future with their unparalleled drive for discovery. They're the unsung heroes behind groundbreaking innovations, improving our daily lives bit by bit. Enjoying both the thrill of the quest and the reward of a solution, their contributions make waves in various fields, from medicine to technology.

Clinical Research Scientist Resume Example

Clinical Research Scientists play an integral role in companies by designing, conducting, and analyzing clinical trials to ensure the safety and efficacy of new products. Your resume should showcase your experience with clinical trial phases, regulatory compliance, data analysis, and scientific publication. You need to highlight technical skills such as proficiency in statistical software, knowledge of Good Clinical Practice (GCP) guidelines, and familiarity with Electronic Data Capture (EDC) systems. Soft skills and people skills like effective communication, critical thinking, collaboration, and problem-solving should also stand out. Remember to tailor your resume to highlight specific achievements and quantifiable impacts you've made in previous roles.

Senior Research Scientist Resume Example

Senior Research Scientists shoulder a range of responsibilities, including leading research projects and ensuring the technical direction aligns with the company's strategic goals. When crafting your resume, make sure to detail your experience in project management, data analysis, and publication of research findings, among other things. Being proficient in software tools like MATLAB, Python, and various data visualization technologies is going to make your hard skills stand out. Moreover, showcasing your ability to work collaboratively, mentor junior scientists, and communicate complex ideas clearly to non-technical stakeholders is super important. Always remember that a well-crafted resume for a Research Scientist should be both comprehensive and concise, leaving a strong impression without overwhelming the reader.

Junior Research Scientist Resume Example

Junior Research Scientists handle the foundational research that supports a company's innovation and product development. On your resume, you should definitely include responsibilities such as conducting experiments, analyzing data, and collaborating with senior researchers. Highlight hard skills like proficiency in advanced statistical software, laboratory techniques, and experience with specific technologies pertinent to your field. Soft skills shouldn't be overlooked; make sure to mention communication abilities, teamwork, and problem-solving skills. Always remember, your resume must clearly demonstrate your successful contributions to past projects to stand out.

Lead Research Scientist Resume Example

Lead Research Scientists are at the helm of innovation in a company, guiding exploration and development in their field of expertise. Their resumes must reflect skills in project management, data analysis, and strategic planning while showcasing successful past projects and collaborations. Highlighting hard skills like proficiency in Python, R, and advanced statistical methods will set you apart from the crowd. Don't forget to emphasize your communication and teamwork capabilities, as these are just as important in a collaborative research environment. Above all, a Research Scientist's resume should clearly demonstrate a continuous commitment to learning and staying updated with the latest scientific advancements.

Associate Research Scientist Resume Example

Associate Research Scientists play a pivotal role in conducting experiments, analyzing data, and contributing to the development of new products or solutions within a company. Your resume should list responsibilities like designing experiments, managing lab equipment, and publishing findings in peer-reviewed journals. Highlight hard skills such as proficiency in PCR, data analysis software, and advanced statistical methods. Don’t forget to include soft skills like teamwork, project management, and effective communication. Remember to underscore any peer-reviewed publications or patents, as they can significantly bolster your credibility.

Looking for more specific tips? Check all related jobs’ resume guides here:

• Senior Research Scientist resume
• Junior Research Scientist resume
• Clinical Research Scientist resume
• Associate Research Scientist resume
• Lead Research Scientist resume

The most important tips for Research Scientist resumes:

The first glance at your resume should immediately show a well-organized document. Use clear headings to separate sections such as Contact Information, Education, Experience, Publications, and Skills. Clean formatting such as bullet points and consistent font size makes it easy to read and helps emphasize key details.

List your past positions in reverse chronological order to spotlight your most recent roles first. Use bullet points to detail specific projects, experiments, and research you have conducted, emphasizing the impact and implications of your work. Avoid generic job descriptions and instead highlight outcomes, awards, or recognition that stemmed directly from your efforts.

Specify the technical skills and methodologies that are unique to your field, such as specific laboratory techniques, software programs, or statistical methods. Provide context by mentioning how and where you’ve applied these skills in your research. Demonstrating hands-on experience with the tools and technologies relevant to the job shows your capability and readiness.

Include a separate section for your published work, listing articles, papers, and conference presentations to illustrate your contributions to scientific knowledge. Arrange publications in reverse chronological order, and consider using a consistent citation format for clarity. This section offers tangible evidence of your expertise and engagement with the academic community.

List your degrees, starting with the highest level achieved, such as Ph.D., followed by Master's, and Bachelor's degrees. Mention the institutions, graduation dates, and any notable honors or distinctions. If relevant, include coursework or projects that directly relate to the position you're applying for, showing a continuous learning path that aligns with the role.

Keep your resume to two pages to maintain the reader's attention while providing comprehensive information. Use concise language and focus on the most relevant experiences and achievements. Avoid including unrelated job roles or excessive details that don't directly enhance your scientific profile or qualifications.

Must-Have Sections on a Research Scientist Resume:

Landing a job as a Research Scientist requires a well-organized resume that highlights your expertise and experience.

• Contact information: This needs to be at the top of your resume. It makes it easy for employers to reach out to you. Include your full name, phone number, email address, and possibly LinkedIn profile.
• Professional summary: Give a short overview of your qualifications and career goals. This section helps prospective employers quickly understand your background. Make sure to tailor it to the specific role you’re applying for.
• Education: List your degrees, institutions, and graduation dates. Mention any honors or relevant coursework. This section shows your academic foundation in the field.
• Work experience: Detail positions held, with bullet points highlighting responsibilities and achievements. Provide specific metrics where possible. This section demonstrates your practical experience.
• Skills: Include both technical and soft skills relevant to the role. Use bullet points for readability. This section helps recruiters quickly assess your qualifications.
• Publications and presentations: List any research papers, articles, or presentations you’ve contributed to. Include titles, publication names, and dates. This shows your active involvement in the research community.

Beyond the main sections, including additional ones can help make your resume stand out.

• Awards and honors: Highlight any accolades or recognitions you’ve received. This could be from academic institutions, conferences, or professional organizations. It helps to underline your achievements and acknowledgment by the community.
• Certifications: Mention any certifications related to research skills and techniques. Include the certificating body and the year obtained. This shows your commitment to continuous learning and professional development.
• Professional memberships: List relevant professional organizations you’re a member of. This includes societies and networks in your field. It signals your dedication and engagement with the broader professional community.

How to Write Your Research Scientist Resume Experience Section

As a research scientist, your resume should highlight your significant contributions to scientific knowledge and underscore your ability to innovate within the lab. Your work experience section should be crafted to exhibit a blend of your technical skills, methodologies applied, and successful project outcomes. This will give potential employers a clear snapshot of your capabilities and past achievements. Below are practical tips to effectively showcase your experience as a research scientist.

• Highlight your key responsibilities by detailing your core tasks and duties. Explain your role in different projects, programs, or experiments. Use specific terminologies relevant to your field to demonstrate your expertise.
• Quantify your achievements wherever possible. If you led a project that resulted in a notable discovery, mention the impact and any measurable outcomes. Numbers can provide a clearer picture of your contributions.
• Discuss collaborations with other departments or researchers. Explain the nature of these collaborations and how they contributed to the success of a project. This shows your ability to work in team settings.
• Include any grants or funding you secured. Detail how you obtained the funding and its purpose. This showcases your ability to support your research initiatives financially.
• Mention any publications, patents, or presentations. List the peer-reviewed journals where your work has been published or any conferences where you presented. This signifies your contribution to the scientific community.
• Describe the methodologies and technologies you used. Specify any advanced techniques, equipment, or software you are proficient in. This demonstrates your technical expertise and adaptability to new tools.
• Emphasize problem-solving skills by mentioning how you addressed specific challenges. Illustrate the steps you took and the innovative solutions you implemented. This highlights your critical thinking and creativity.
• Include leadership roles and responsibilities. If you supervised a team or managed a lab, describe your managerial tasks. Leadership experience adds weight to your ability to guide and mentor others.
• Talk about any regulatory compliance and safety protocols you followed. Emphasize your commitment to maintaining high standards of safety and ethics in your research. This shows your observance of industry regulations and standards.
• List any awards or recognition you have received. Point out any accolades that speak to your excellence and impact in your research field. Awards can significantly boost your credibility.

Next, we’ll demonstrate how to quantify your experience effectively, identify common responsibilities that HR managers typically look for on your resume, and how to more specifically customize it to align with job descriptions. For those at the entry-level or applying for internships, we’ll also discuss strategies to downplay your lack of experience.

Examples of How To Quantify Your Experience

• Increased efficiency of experimental workflows by 35% through development and implementation of automated data analysis pipelines, resulting in a $50,000 annual cost saving.
• Published 12 peer-reviewed articles in high-impact journals with an average impact factor of 8.5, contributing to a 20% increase in departmental research visibility.
• Secured $1.2 million in grant funding by writing and presenting compelling research proposals, supporting the continuation and expansion of critical projects.
• Mentored 5 PhD students and 3 postdoctoral researchers, leading to 4 successful dissertation defenses and 6 published co-authored papers.
• Developed a novel algorithm for protein structure prediction that improved accuracy by 25% and was adopted by 3 leading pharmaceutical companies.
• Led a cross-functional team of 10 researchers, engineers, and technicians on a project that reduced drug development time by 18 months and lowered R&D costs by 15%.
• Presented research findings at 7 international conferences, resulting in collaborations with 4 universities and 2 industry partners.
• Generated over 200 citations for key publications within 2 years, significantly enhancing the scientific community's engagement with our research.
• Initiated a collaborative study with a prestigious institution, leading to a joint publication that won the Best Paper Award at a major symposium.
• Developed and validated a new diagnostic assay that increased detection sensitivity by 40%, now in use in over 50 clinical laboratories worldwide.
• Designed and executed 15 complex experiments that resulted in the discovery of 2 novel biomarkers, advancing personalized medicine research.
• Improved lab safety compliance by 22% through the implementation of stringent safety protocols and regular training sessions for all lab personnel.
• Managed a project budget of $500,000, ensuring on-time and within-scope delivery of 4 key milestones, leading to an additional $300,000 in follow-up funding.
• Developed a machine learning model for analyzing genomic data, which increased prediction accuracy by 30% and was shared with research teams in 10 institutions.
• Identified and patented 3 novel compounds with potential therapeutic applications, significantly contributing to the intellectual property portfolio of the institution.

Job Description Bullet Points on Research Scientist Resumes:

• Conduct thorough literature reviews to identify gaps in existing research and establish a foundation for new scientific studies.
• Design and implement experimental protocols, ensuring adherence to regulatory guidelines and industry best practices.
• Develop and validate analytical methods to quantify and qualify research results for accurate data interpretation.
• Collaborate with cross-functional teams, including engineers, product managers, and clinical researchers, to align project objectives.
• Utilize advanced statistical tools and computational models to analyze complex datasets and derive meaningful insights.
• Present research findings at scientific conferences, seminars, and meetings to disseminate knowledge and gain feedback.
• Supervise and mentor junior researchers, providing guidance and support in their professional development and project execution.
• Author and co-author peer-reviewed publications to communicate discoveries and advancements to the scientific community.
• Secure funding through grant proposals by identifying potential funding sources and articulating the significance of research projects.
• Maintain accurate and detailed records of research activities, experimental procedures, and resultant data for reproducibility and audit purposes.
• Ensure compliance with safety protocols and ethical standards in all laboratory practices and research activities.
• Coordinate with external partners, including academic institutions, industry stakeholders, and regulatory agencies, to facilitate collaborative research efforts.
• Lead the development and refinement of research hypotheses based on preliminary findings and emerging scientific trends.
• Manage research budgets, including allocation of resources and procurement of necessary equipment and supplies.
• Contribute to the creation of patents by documenting innovative methodologies and discoveries for intellectual property protection.

How to Tailor Your Research Scientist Resume To the Job Description:

• Focus on the qualifications mentioned in the job listing. Describe your previous roles highlighting these qualifications. Say how your past roles make you a perfect fit.
• Bring attention to relevant projects that align with job requirements. Describe the outcomes and the impact on your previous employer. Mention specific tools or methodologies used.
• Highlight any collaborations with teams or departments directly tied to the job. Explain the nature of these interactions and outcomes. Mention skills that reflect teamwork and communication.
• Include data and statistics to show your contributions. Employers love seeing quantified results demonstrating your effectiveness. Showcase improvements you made through your initiatives.
• Reflect the terminology and language used in the job description. This helps with the ATS parsing similar skills and experiences. Ensures your expertise matches job requirements closely.
• Emphasize unique skills you possess that the job requires. Describe instances where you applied these in your previous roles. Make connections between your background and position you're targeting.

How to Write Your Resume Summary/Objective Section

The summary section of a resume for a Research Scientist positions you effectively within the competitive job market. It highlights your key achievements, skills, and areas of expertise in a concise manner. A well-crafted summary can make you stand out to recruiters who often have limited time to review each candidate. Be clear and compelling in showcasing your capabilities and contributions to previous research projects.

The primary difference between a resume summary and an objective is their focus and purpose. A summary gives a brief overview of your professional experience and qualifications, while an objective outlines your career goals and the value you aim to bring to the employer. For a Research Scientist role, using a summary can be more impactful as it emphasizes your experience and specific skills. Employers often look for those who can directly contribute to their ongoing or future projects.

• Highlight significant contributions you made to research projects and your role in them. Provide specific details on what research topics you focused on. Mention any noteworthy publications or presentations derived from your research.
• Emphasize your technical skills and methodologies you are proficient in. This can include lab techniques, data analysis, and any specialized equipment you have used. Clearly explain how these skills have been applied in your past roles.
• Include collaborations with other researchers, institutions, or interdisciplinary teams. State the purpose of these collaborations and the outcomes. Showing you can work well with others is crucial in a research setting.
• Articulate your problem-solving abilities and innovative approaches to research challenges. Provide examples of complex problems you’ve addressed and the methodologies you applied. Talk about the impact of your solutions on the project or organization.
• Detail your commitment to staying updated with the latest scientific developments. Mention conferences, workshops, or courses you’ve attended. It shows your dedication to continuous learning and improvement in your field.
• Discuss your mentorship or leadership roles if applicable. Mention how you’ve guided junior researchers or led a project team. This indicates your potential to take on greater responsibilities within a new role.

Now, let's move on to see actual examples that can illustrate these tips effectively.

Resume’s personal statement examples:

• Experienced Research Scientist with over 10 years in molecular biology and biochemistry, adept at leading cross-functional teams and managing multi-million dollar research projects from conception to completion.
• Innovative Research Scientist specializing in nanotechnology and materials science, with a proven track record of authoring high-impact publications and securing competitive research grants.
• Results-driven molecular biologist with extensive experience in CRISPR and gene editing technologies, dedicated to advancing human health through innovative research and collaborative efforts.
• Aspiring Research Scientist with a strong foundation in organic chemistry and analytical techniques, seeking to leverage hands-on laboratory experience in a challenging and dynamic research environment.
• Passionate Research Intern with proficiency in data analysis and laboratory techniques, aiming to contribute to impactful research projects and gain deeper insights within the fields of pharmacology and medicinal chemistry.
• Diligent Research Assistant with hands-on experience in ecological and environmental studies, skilled in fieldwork, data collection, and laboratory analysis, eager to support groundbreaking environmental research.

Top Resume Skills for Research Scientist

The top skills, expertise, and competencies for a Research Scientist are varied but fundamentally center around a few key areas. Critical thinking and analytical skills are the backbone of any effective research and allow for detailed examination and innovative problem solving. Technical proficiency, especially in relevant software and laboratory techniques, is indispensable. Communication skills are also essential, as complex data must be presented clearly and concisely to both academic and lay audiences.

• Highlight your technical skills in specific areas such as software proficiency and laboratory techniques. Mention specific tools or software that you've mastered, like Python, R, or any specialized research tools. Make sure to align these with the job requirements you are applying for.
• Showcase your ability to design and conduct experiments or studies. Mention any relevant experience with experimental design, data collection, and data analysis. Highlight how your work has contributed to advancing knowledge in your field.
• Include soft skills that demonstrate your ability to work in a collaborative environment. For instance, cite teamwork and your role in interdisciplinary projects. Emphasize your communication skills, both written and verbal.
• Detail your publication and presentation experience. List any journals you've been published in or conferences you've presented at. Mention the effectiveness of your communication in these forums.
• Show your track record of problem-solving and innovative thinking. Describe situations where you successfully identified a problem and developed a solution. Discuss the impact of your solutions on your project or field.
• List any relevant certifications or special training you've received. Include any continuing education courses, certifications in specialized research techniques, or relevant professional affiliations. This shows your commitment to staying current in your field.

Next, we’ll provide a list of skills to help you craft an effective resume for a Research Scientist position.

Top Hard Skills for Research Scientist Resumes

• Data Analysis
• Statistical Methods
• Molecular Biology Techniques
• Programming
• Machine Learning
• Experimental Design
• Biochemical Assays
• Genomic Data Analysis
• Mass Spectrometry
• Bioinformatics
• Scientific Writing
• High-Performance Computing
• Lab Management

Top Soft Skills for Research Scientist Resumes

• Critical Thinking
• Attention to Detail
• Communication
• Problem Solving
• Collaboration
• Adaptability
• Time Management
• Interpersonal Skills
• Organizational Skills
• Project Management
• Conflict Resolution

Include a Research Scientist Cover Letter for a Stand-Out Application

Cover Letter Writing Tips for Research Scientist Applicants

Writing a compelling cover letter is crucial for a Research Scientist aiming to stand out in job applications. This opening document introduces your skills and experience, setting the stage for your resume. It's more than just a formality; it's your first opportunity to engage with potential employers. Let's explore some practical advice to make your cover letter truly impactful.

• Start with a strong opening sentence that grabs attention immediately while indicating your enthusiasm for the role at their company. Mention how you found out about the position, be it through a job board or a professional connection. This makes your application feel more personalized and shows your initiative.
• Discuss your most relevant experience early on in the letter. Focus on specific achievements or projects that relate closely to the job you're applying for. This helps make your cover letter targeted and showcases your suitability for the position.
• Use keywords from the job description. If they mention certain technologies, methodologies, or skills, be sure to incorporate those into your experience. This can help your cover letter pass through automated screening tools.
• Provide concrete examples of your skills. If the job description highlights data analysis, share an example of a research project where your analysis led to significant findings. Specific anecdotes make your abilities more vivid and reliable.
• Avoid generic phrases and clichés. Instead of saying you're a "hard worker" or "detail-oriented," show this through your work or achievements. Personal stories tend to be much more convincing than overused adjectives.
• Keep your tone professional yet human. While you should avoid being overly casual, it's important not to sound like a robot either. Adding a touch of your personality can make your letter more engaging.
• Highlight any unique skills or experiences that differentiate you from other candidates. Maybe you have international research experience or are proficient in an uncommon software. These unique aspects can make a huge difference.
• Be concise and focused, sticking to one page. Avoid long-winded explanations; instead, get to the point swiftly. A well-organized and brief letter is often more impactful.
• Express your passion for the field and for the company's mission or projects. Employers want to know you’re not just looking for any job, but specifically one with them because of what they do. Show your excitement and genuinely link it to the job role.
• Proofread rigorously for errors in spelling, grammar, and formatting. Mistakes can be distracting and diminish your credibility. Taking the time to review your cover letter shows your attention to detail and your professionalism.

Next, let's discuss how you can align your cover letter seamlessly with your resume.

Frequently Asked Questions

Should my research scientist resume be one page or longer.

Whether your Research Scientist resume should be one page or longer depends largely on your level of experience and accomplishments. If you are early in your career, a one-page resume may be sufficient to showcase your skills, education, and relevant experiences. For more seasoned professionals with extensive publications, research projects, and professional experience, a two-page resume might be necessary to fully capture your qualifications. It is crucial to present your information concisely and ensure that every element adds value to your application, regardless of the length.

What is the best format for a Research Scientist resume?

The reverse-chronological format is often the most effective for a Research Scientist resume. This format allows you to highlight your most recent and relevant experiences first, which can be an immediate draw for hiring managers. By organizing your work history from the most recent to the earliest, you provide a clear and easy-to-follow timeline of your career progression. This format is particularly beneficial for those with a steady career path in research, as it emphasizes your continuous development and contributions in the field.

What should I highlight on my Research Scientist resume to stand out?

Focusing on your research achievements and contributions is key to making your Research Scientist resume stand out. Emphasize your publications, grants, and significant projects you have worked on. Include any prestigious awards or recognitions you have received. Make sure to detail specific methodologies or techniques you have become proficient in, especially those relevant to the job you are applying for. Additionally, showcasing your collaborative work with other researchers and institutions can also highlight your ability to work well in team settings.

What are some action verbs I should use on my Research Scientist resume?

To make your Research Scientist resume more dynamic and impactful, incorporate action verbs like 'developed,' 'analyzed,' 'conducted,' 'published,' 'presented,' 'collaborated,' 'innovated,' 'designed,' and 'engineered.' These words not only describe your responsibilities but also highlight your proactive role in driving research forward. Using action verbs ensures your resume conveys both your competence and your active contributions to your field.

For more inspiration, why not check out our free resource of job-focused resume examples?

When creating a dog sitter resume in 2024, there are a few key formatting considerations to keep in mind. First, keep the resume length to one page to ensure that hiring managers can quickly and easily review your qualifications. Additionally, choose a clean and professional design that is easy to read and navigate. Remember, the format of your resume should effectively showcase your skills and experience while maintaining a polished and organized appearance. To make a strong impression as a dog sitter, there are several essential sections you should include on your resume. These include: Summary or Objective Statement: Begin your resume with a brief summary or objective that highlights your experience, skills, and passion for working with dogs. Experience: In this section, provide detailed information about your previous dog sitting roles, including the duration of each position and any specific responsibilities or achievements. Education: List any relevant education or certifications related to dog sitting, such as completion of a dog training course or membership in a professional dog sitters association. Skills: Include a section that highlights your specific skills as a dog sitter, such as knowledge of dog behavior, ability to administer medications, or familiarity with various breeds. References: If you have references from satisfied clients or employers, consider including them in a separate section or upon request. While the sections listed above are crucial, there are also a few optional but impactful sections you may choose to include. These can include additional certifications, volunteer work or relevant hobbies. Remember to prioritize the sections that best showcase your qualifications and align with the requirements of the dog sitter role you are applying for. To effectively communicate your experience as a dog sitter on your resume, it is recommended to use the Context-Action-Result (CAR) framework. This framework allows you to clearly articulate the situation you encountered, the actions you took, and the results you achieved. Here are a few examples of bullet points using the CAR framework: Context: Managed a roster of 10+ clients with varying dog breeds, sizes, and temperaments. Action: Conducted initial meet-and-greets to assess dogs' needs and establish rapport with owners; implemented personalized care plans for each dog. Result: Ensured the well-being and happiness of all dogs in my care, resulting in positive client feedback and repeat business. Context: Assisted in training dogs through positive reinforcement techniques and proper leash handling. Action: Developed and implemented customized training plans tailored to each dog's specific needs and behavior challenges. Result: Helped improve dogs' obedience and overall behavior, resulting in happier and more enjoyable experiences for both dogs and their owners. By using the CAR framework, you can effectively showcase your skills, experience, and the positive impact you have made in previous dog sitting roles. In summary, when creating a dog sitter resume in 2024, remember to: Keep the resume length to one page and choose a clean, professional design. Include essential sections such as a summary, experience, education, skills, and references. Consider including optional sections such as additional certifications or relevant volunteer work. Use the Context-Action-Result framework to highlight your experience with clear and impactful bullet points. By following these guidelines, you can create a standout dog sitter resume that will impress potential employers and increase your chances of landing your dream job in the pet care industry.

Leasing Agent

Leasing Agents are the gatekeepers to new beginnings, connecting people with their dream homes. They turn the abstract concept of "home" into a concrete reality for many. Through their expertise, they help prospective tenants make one of the most important decisions of their lives. To succeed, Leasing Agents must have great communication skills and the ability to build relationships quickly. Prospective employers are looking for candidates who are confident in their sales capabilities and can manage multiple tasks efficiently. When crafting your Leasing Agent resume, highlighting these skills and experiences is crucial.

Alliance Manager

Formatting Your Resume When it comes to creating a resume for an Alliance Manager position in 2024, there are a few key factors to keep in mind to ensure your application stands out. First and foremost, pay attention to the length of your resume. In today's competitive job market, hiring managers typically spend just a few seconds scanning each resume. *Therefore, it's crucial to keep your document concise and focused.* Aim for a one-page resume that highlights your most relevant skills and experiences. In terms of design, a clean and professional look is essential. *Choose a simple and modern font,* such as Arial or Calibri, and use appropriate font sizes for headings and body text to ensure readability. Don't forget to *use bullet points* to organize information and make it easier for hiring managers to skim through your resume. Sections to Include To create a comprehensive Alliance Manager resume, consider including the following sections: 1. Contact Information: Start your resume with your name, contact information, and professional links, such as LinkedIn or a personal website, if applicable. 2. Summary: Craft a concise summary that highlights your key qualifications and experiences as an Alliance Manager. 3. Skills: List relevant skills, both technical and soft, such as partnership development, contract negotiation, project management, and strategic planning. 4. Experience: This section is crucial for showcasing your relevant work history. Use the Context-Action-Result framework to effectively communicate your accomplishments and impact in previous roles. 5. Education: Include your educational background, degrees, and any relevant certifications. 6. Awards and Recognition: If you have received any professional awards or recognition, include them in this section. Remember, these sections are not set in stone, and you can customize your resume according to your specific experiences and industry preferences. *Optional but still impactful sections* may include volunteering experience, professional affiliations, or publications. Writing About Your Experience When describing your experience as an Alliance Manager, it's important to highlight your achievements and contributions using the Context-Action-Result (CAR) framework. This framework enables you to provide context for the situation, describe the actions you took, and showcase the outcomes or results achieved. Here are a few examples of bullet points that align with this framework: 1. Context: Managed strategic alliances with key industry partners in the technology sector. - Action: Developed and executed partnership agreements, including terms on revenue sharing, joint marketing campaigns, and product integration. - Result: Increased revenue by 20% within the first year of partnership, resulting in a significant market share growth. 2. Context: Led cross-functional teams to develop and implement alliance strategies for expanding into new geographic markets. - Action: Conducted market research, identified potential partners, and negotiated mutually beneficial agreements. - Result: Successfully entered and established a strong presence in three new markets, resulting in a 30% increase in overall revenue. 3. Context: Oversaw the alliance program, including partner onboarding, enablement, and performance evaluations. - Action: Implemented a partner training program to enhance knowledge sharing and collaboration. - Result: Improved partner satisfaction by 25% and increased the number of active partnerships by 40%. Key Takeaways - Keep your resume concise and focused, aiming for a one-page document with a clean and professional design. - Include sections such as Contact Information, Summary, Skills, Experience, Education, and Awards. - Use the Context-Action-Result framework to highlight your achievements and outcomes in previous roles as an Alliance Manager. - Customize your resume to emphasize your specific experiences and industry preferences. - Proofread your resume carefully and consider seeking feedback from professionals in your field. Remember, your resume is your first opportunity to make a positive impression on potential employers. *By following these guidelines and tailoring your resume to the Alliance Manager position, you can increase your chances of landing an interview and securing your dream job.*