clinical research associate job responsibilities

Clinical Research Associate: Roles & Responsibilities

Introduction

Clinical research plays a pivotal role in advancing medical knowledge and patient care. At the heart of this process are Clinical Research Associates (CRAs), professionals who ensure the efficacy and safety of clinical trials. As the pharmaceutical and biotechnology industries expand, so does the demand for skilled CRAs. This blog aims to demystify the roles and responsibilities of a CRA and highlight the significance of this career in the realm of clinical research.

A Clinical Research Associate is a professional who monitors the administration and progress of a clinical trial (a research study that tests how well new medical approaches work in people). Typically, CRAs hold a degree in pharmacy, life sciences, nursing, or a related field, combined with substantial knowledge of clinical research protocols. They are the linchpins in the development of drugs, biologics, and medical devices, bridging the gap between the clinical trial process and regulatory compliance.

Key Responsibilities of a Clinical Research Associate

1. site selection and preparation.

CRAs are involved in selecting suitable sites for clinical trials, and assessing the capabilities of a site to conduct the trial. This involves evaluating the staff’s qualifications, the facility’s equipment, and the site’s patient population. They also play a key role in preparing the site for the study, ensuring that each site has the necessary materials and training to conduct the trial according to protocol.

2. Protocol Development and Implementation

CRAs contribute to developing the clinical trial protocol, a document that outlines the objectives, design, methodology, statistical considerations, and organization of a trial. They ensure that the trial is implemented as per the protocol and that any deviations are documented and justified.

3. Subject Recruitment and Consent

A crucial aspect of a CRA’s role is facilitating the recruitment of subjects for the trial. They ensure that potential subjects are properly informed about the trial and that informed consent is obtained in accordance with regulatory requirements.

4. Monitoring Clinical Trials

CRAs regularly visit trial sites to monitor the progress of the trial. They verify that the clinical trial data recorded by investigators is accurate and that the trial is being conducted in compliance with the protocol, Good Clinical Practice (GCP), and regulatory requirements.

5. Ensuring Compliance

CRAs ensure that clinical trials comply with regulatory standards and ethical guidelines. They are responsible for understanding and keeping up to date with regulations and guidelines, such as those set by the FDA or EMA.

6. Data Management and Reporting

Managing and overseeing the data collected during clinical trials is another key responsibility. CRAs review data for accuracy and completeness and assist in preparing reports on the trial’s findings.

Challenges Faced by Clinical Research Associates

CRAs often face challenges such as managing responsibilities across multiple trial sites, ensuring data integrity, and adapting to constantly changing regulatory environments. Problem-solving skills, adaptability, and a keen eye for detail are essential traits for success in this role.

The Future of Clinical Research Associates

The role of a CRA is evolving with advancements in technology and changes in the regulatory landscape. CRAs are increasingly involved in virtual or remote monitoring of trials, using digital tools to manage and oversee trial progress. As the field grows, so do the career paths and advancement opportunities for CRAs.

Clinical Research Associates play a critical role in the success of clinical trials. They ensure that trials are conducted ethically, efficiently, and in compliance with regulatory standards. The role of a CRA is not only challenging and demanding but also highly rewarding, contributing significantly to the advancement of medical research and patient care.

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Clinical Research Associate Job Description [Updated for 2024]

In the modern healthcare industry, the role of Clinical Research Associates is indispensable.

As the healthcare landscape progresses, the demand for skilled professionals who can execute, manage, and ensure the quality of clinical research escalates.

Let’s delve deeper: What is truly expected from a Clinical Research Associate?

Whether you are:

• A job seeker wanting to understand the core aspects of this role,
• A hiring manager outlining the perfect candidate,
• Or simply fascinated by the intricacies of clinical research,

You’ve found the right place.

Today, we present a customizable Clinical Research Associate job description template, designed for effortless posting on job boards or career sites.

Let’s dive right in.

Clinical Research Associate Duties and Responsibilities

Clinical Research Associates play a crucial role in clinical trials and research studies.

They are involved in every stage of the process, from planning to data collection, analysis, and reporting.

They often work in a team with other scientists, researchers, and healthcare professionals.

Their duties and responsibilities include:

• Designing and implementing clinical research studies and trials
• Preparing protocols for clinical trials
• Monitoring the progress of research activities and ensuring they adhere to protocols
• Collecting, processing, and managing research data
• Conducting site visits, field monitoring, and data auditing
• Ensuring all research activities comply with regulatory standards and ethical guidelines
• Preparing reports and presentations to communicate research findings
• Communicating with clinical study sponsors, investigators, and other team members
• Participating in patient recruitment and screening activities
• Coordinating and managing logistics of clinical trials, including materials, equipment, and participant care
• Training and supervising junior staff and ensuring they adhere to clinical trial protocols and standards

Clinical Research Associate Job Description Template

We are looking for a dedicated Clinical Research Associate to assist with the design, execution, and maintenance of clinical trials.

The Clinical Research Associate’s responsibilities include creating and implementing research protocols, interpreting the data, writing reports, and ensuring all trials are conducted in compliance with the clinical protocol, and regulatory and ethical standards.

Our ideal candidate has experience in a clinical research environment, with a strong understanding of medical terminology, clinical trials, and research protocols.

Responsibilities

• Assist in the design and development of clinical research protocols
• Monitor clinical trials and studies to ensure compliance with protocol
• Coordinate with clinical investigators and staff to resolve queries and manage data
• Prepare and present detailed reports and documents for clinical trials and studies
• Conduct periodic site visits to ensure protocol adherence and integrity of collected data
• Ensure all adverse events are reported in a timely and accurate manner
• Maintain regulatory documentation according to the regulatory requirements
• Participate in the preparation and review of study reports and manuscripts

Qualifications

• Proven work experience as a Clinical Research Associate
• Knowledge of good clinical practices (GCP), FDA regulations and guidelines
• Excellent understanding of medical terminology, clinical trials, and research protocols
• Proficiency in data analysis and documentation
• Strong organizational and communication skills
• Ability to travel for monitoring visits
• Bachelor’s degree in Life Sciences, Nursing or a related field
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Additional Information

• Job Title: Clinical Research Associate
• Work Environment: Clinical settings, with options for remote work. Travel is required for site visits and meetings with clinical investigators.
• Reporting Structure: Reports to the Clinical Research Manager or Clinical Operations Manager.
• Salary: Salary is commensurate with experience and qualifications, as well as market and business considerations.
• Pay Range: $60,000 minimum to $90,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

What Does a Clinical Research Associate Do?

Clinical Research Associates (CRAs) primarily work for pharmaceutical and biotechnological companies, contract research organizations, or government health departments.

They play a critical role in the research and development of new drugs, medical devices, and procedures.

They are responsible for setting up, monitoring, and completing clinical trials, which are tests or studies done to evaluate the effects of medical or surgical interventions on human subjects.

CRAs are responsible for ensuring the trials adhere to the trial protocol, are conducted ethically, and are in compliance with regulatory standards and guidelines.

They also ensure that data collected from the trials is accurate, complete, and verifiable from source documents.

Their job involves frequent travel to the clinical trial sites to monitor the progress of the trial, review the data collected, and to ensure the safety and wellbeing of the trial participants.

They are also involved in the design and writing of trial protocols, case report forms, and consent forms, and work closely with doctors, other healthcare professionals, and trial participants.

In addition, they may also liaise with regulatory authorities and ethics committees regarding the approval of trial protocols, amendments, and serious adverse event reports.

Their role is critical in the drug development process and contributes significantly to the advancement of medical science and patient care.

Clinical Research Associate Qualifications and Skills

Clinical Research Associates should have a set of skills and qualifications that align with the job description, including:

• Thorough knowledge of clinical research principles, regulations and procedures to ensure compliance with ethical, legal and safety requirements.
• Strong analytical and critical thinking skills to evaluate and interpret clinical data and identify any inconsistencies or deviations.
• Excellent attention to detail in order to accurately document and report results from clinical trials.
• Strong organizational and time management skills to manage multiple tasks, prioritize effectively, and meet deadlines.
• Effective communication skills to clearly and effectively interact with all levels of clinical staff and participants, and to write comprehensive reports.
• Interpersonal and team working skills to collaborate with a diverse team of professionals such as clinical investigators, medical specialists, and laboratory technicians.
• Problem-solving skills to address and resolve any issues or obstacles that may arise during the conduct of clinical trials.
• Ability to remain adaptable and resilient in high-stress situations or when dealing with unexpected results or challenges.

Clinical Research Associate Experience Requirements

For entry-level Clinical Research Associate positions, candidates usually need 1 to 2 years of relevant experience, which can be obtained through internships, part-time roles, or relevant healthcare positions.

These professionals may also gain experience in roles such as Clinical Research Coordinator, Clinical Data Analyst, or other healthcare-related roles.

Candidates with more than 2 years of experience often develop their clinical research skills and knowledge in entry-level Clinical Research Associate roles or similar positions, where they gain hands-on experience in clinical trial procedures, regulatory requirements, and data management.

Those with more than 5 years of experience may have some leadership experience in their background and are usually ready for roles such as Senior Clinical Research Associate or Clinical Trial Manager.

They may also have completed advanced training or certifications related to clinical research or the specific field of study.

Additionally, many employers prefer candidates with a background in life sciences, nursing, or medical sciences.

Advanced degrees such as a Master’s or PhD in a relevant field can also substitute for some experience requirements.

Clinical Research Associate Education and Training Requirements

Clinical Research Associates (CRA) typically require a bachelor’s degree in life sciences, medical sciences, nursing, or related field.

They also need to have a good understanding of clinical research processes, medical terminologies, and regulatory standards.

Familiarity with Good Clinical Practice (GCP) is also essential.

Many employers prefer candidates with a master’s degree in a health-related field or an equivalent combination of education and experience.

Courses in biostatistics, clinical trials design, and ethics are particularly beneficial for this role.

Some positions may require CRAs to have certification from organizations such as the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA).

This certification typically requires a combination of education, experience, and a passing score on an examination.

Continuing education is crucial in this field as regulatory guidelines and medical knowledge continually evolve.

Advanced coursework or training in clinical data management, ethics, and patient safety can prove highly beneficial.

Work experience in clinical research is highly valued, which can be obtained through internships, cooperative programs, or direct employment in healthcare facilities or research laboratories.

The role also demands excellent communication, attention to detail, organizational skills, and the ability to handle multiple tasks simultaneously.

Clinical Research Associate Salary Expectations

A Clinical Research Associate can expect an average salary of $76,506 (USD) per year.

The actual earnings can vary significantly depending on factors such as the level of experience, education, the employing company, and the location of the job.

Clinical Research Associate Job Description FAQs

What skills does a clinical research associate need.

A Clinical Research Associate should possess excellent analytical and organizational skills to effectively manage the research process.

They must have strong attention to detail to ensure the accuracy of data and should have excellent written and verbal communication skills to clearly present findings.

Moreover, they should have a deep understanding of clinical trial processes and be able to work collaboratively with various medical professionals.

Do Clinical Research Associates need a degree?

Yes, a bachelor’s degree in life sciences or a related field is typically required for entry-level positions.

However, a master’s degree or a Ph.D. is often preferred, especially for more senior roles.

Clinical Research Associates also require extensive training in clinical practices, ethics, and regulations.

What should you look for in a Clinical Research Associate resume?

When reviewing a Clinical Research Associate’s resume, look for a degree in life sciences or a related field, and any additional qualifications or certifications in clinical research.

You should also look for experience in clinical trials, including study design, data collection and analysis, and report writing.

Proficiency in using clinical research software and familiarity with FDA regulations and Good Clinical Practice (GCP) guidelines is also important.

What qualities make a good Clinical Research Associate?

A good Clinical Research Associate is a critical thinker, able to analyse complex data and identify trends or patterns.

They are meticulous, ensuring that every detail of the research process is accurately documented and reported.

They are also ethical, ensuring that all research is conducted in line with established protocols and guidelines.

Good Clinical Research Associates are also proactive, able to anticipate and resolve issues before they become problems.

What are the daily duties of a Clinical Research Associate?

A Clinical Research Associate’s daily duties typically include designing and implementing clinical trials, collecting and analyzing data, conducting site visits, and ensuring compliance with protocol.

They monitor progress of studies, ensuring they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.

They may also spend time liaising with doctors or consultants, writing reports, and presenting findings.

There you have it.

Today, we’ve delved deep into the intricacies of what it truly means to be a Clinical Research Associate .

It’s not just about conducting research.

It’s about shaping the future of healthcare, one research study at a time.

With our comprehensive Clinical Research Associate job description template and real-world examples, you’re now ready to take that leap.

But why settle there?

Dig deeper with our job description generator . It’s your essential tool for developing laser-focused job listings or honing your resume to perfection.

Every research study contributes to the bigger picture.

Let’s shape the future of healthcare. Together.

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Clinical Research Associate

Job description, salary, resume, and interview questions, table of contents, what does a clinical research associate do.

Clinical Research Associates (CRAs) play a vital role in managing and monitoring clinical trials to evaluate the effectiveness and safety of new treatments, therapies, and medical devices. This position involves overseeing clinical study protocols, ensuring compliance with regulatory requirements, and collecting and analyzing data to ensure accuracy and integrity throughout the research process. CRAs collaborate with research teams, healthcare professionals, and regulatory bodies to ensure that clinical trials are conducted efficiently, ethically, and in accordance with established guidelines.

Successful Clinical Research Associates are characterized by their strong organizational skills, attention to detail, and the ability to manage multiple aspects of clinical trials simultaneously. They demonstrate excellent communication skills, maintain strict adherence to confidentiality, and navigate complex regulatory environments to ensure the success and compliance of clinical research projects.

AVERAGE SALARY FOR Clinical Research Associate

Salaries can vary depending on factors such as geographical location, experience, educational background, and industry sector.

Clinical Research Associate Job Descriptions

Below are four types of Clinical Research Associate job descriptions, detailing the range and expectations of the role:

Job Description: We are seeking an experienced Field Clinical Research Associate to manage the day-to-day operations of clinical trials across various research sites. The ideal candidate will ensure study protocols are followed, monitor patient recruitment, and maintain communication between research teams and sponsors.

Responsibilities:

• Oversee the conduct of clinical trials at assigned research sites.
• Ensure compliance with clinical trial protocols and regulatory guidelines.
• Monitor the recruitment and enrollment of study participants.
• Perform site visits to verify trial progress, patient safety, and adherence to study protocols.
• Communicate with investigators, site staff, and sponsors to resolve issues and ensure smooth trial operations.
• Maintain accurate and up-to-date trial documentation.

Qualifications:

• Bachelor’s degree in a life sciences field or equivalent.
• Experience in clinical research, preferably as a CRA.
• Knowledge of GCP, ICH guidelines, and regulatory requirements.
• Strong organizational and communication skills.
• Ability to travel extensively as needed for site visits.

Job Description: We are seeking a detail-oriented Regulatory Clinical Research Associate to ensure that clinical trials comply with all regulatory and ethical requirements. The ideal candidate will have experience working with regulatory bodies to obtain approvals and manage compliance throughout the study lifecycle.

• Prepare and submit regulatory documents to obtain approval for clinical trials.
• Ensure adherence to regulatory requirements, including ICH-GCP and local regulations.
• Liaise with regulatory authorities, ensuring timely submission of study-related documents.
• Monitor the progress of regulatory submissions and approvals.
• Advise the clinical trial team on regulatory and compliance matters.
• Bachelor’s degree in life sciences or related field.
• Experience in regulatory affairs or clinical research, with a focus on compliance.
• Knowledge of FDA, EMA, and other regulatory bodies’ guidelines.
• Strong communication skills for interacting with regulatory agencies and internal teams.
• Detail-oriented with excellent organizational skills.

Job Description: We are seeking a Project Clinical Research Associate to oversee the entire lifecycle of clinical trials. The ideal candidate will manage timelines, budgets, and resources while ensuring the accurate and timely execution of clinical studies from initiation through closeout.

• Manage and oversee all aspects of clinical trials, including study timelines, budgets, and resources.
• Coordinate with the study team to ensure that all milestones are achieved on time and within budget.
• Ensure that clinical trial documentation is accurate and compliant with regulations.
• Monitor and report on trial progress, addressing any issues that arise during the study.
• Collaborate with sponsors, CROs, and other stakeholders to ensure smooth trial execution.
• Proven experience in project management within the clinical research field.
• Strong knowledge of clinical trial regulations, ICH-GCP, and project management best practices.
• Excellent communication, organizational, and problem-solving skills.
• Ability to work independently and manage multiple projects simultaneously.

Job Description: We are seeking a Clinical Data Management Associate to oversee data collection, validation, and management during clinical trials. The ideal candidate will ensure data quality, accuracy, and completeness, while ensuring compliance with regulatory standards.

• Collect, validate, and manage clinical trial data to ensure accuracy and completeness.
• Review and clean data to identify discrepancies and resolve issues.
• Collaborate with the clinical team to ensure proper data collection procedures are followed.
• Maintain detailed documentation of data-related processes and activities.
• Work closely with biostatisticians to ensure that data is appropriately analyzed and reported.
• Bachelor’s degree in life sciences, biostatistics, or related field.
• Experience in clinical data management or clinical research.
• Knowledge of data management tools and databases (e.g., EDC systems).
• Attention to detail and strong analytical skills.
• Excellent communication skills for working with cross-functional teams.

Tap into TemPositions Health Care network of prescreened and vetted professionals.

Candidate certifications to look for.

Consider the following certifications and qualifications when evaluating candidates:

Offered by the Society of Clinical Research Associates (SoCRA), this certification demonstrates that a CRA has the knowledge and experience required to manage clinical trials effectively, adhering to Good Clinical Practice (GCP) standards. It is widely recognized in the industry as a mark of expertise in clinical research.

Provided by the Association of Clinical Research Professionals (ACRP), the CCRP certification indicates proficiency in the ethical and regulatory requirements for conducting clinical research, including knowledge of trial management, protocol adherence, and subject safety. This certification is valuable for CRAs who want to demonstrate their commitment to the highest standards in clinical research.

GCP certification, available from various accredited organizations and training providers, is essential for CRAs as it ensures their understanding of ethical and regulatory standards in clinical research. It covers topics such as trial design, subject recruitment, and monitoring, and is typically required by employers and regulatory authorities.

HOW TO HIRE A Clinical Research Associate

Securing a skilled Clinical Research Associate requires a strategic approach to identifying professionals with strong knowledge of clinical research protocols, regulatory requirements, and the ability to manage complex trials effectively. Here are key strategies to help you hire top CRA talent:

Comprehensive Job Descriptions: Clearly articulate the responsibilities, qualifications, and skills required for the role to attract candidates who meet the specific needs of your organization.

Clinical Research Competency Assessments: Incorporate hands-on simulations, data analysis exercises, and patient case scenarios as part of the recruitment process to objectively evaluate candidates’ clinical research expertise, knowledge of regulatory compliance, and proficiency in managing trials and patient data.

Focus on Detail Orientation: During interviews, ask questions designed to assess candidates’ attention to detail and their methods for ensuring accuracy in patient care and documentation.

Highlight Opportunities for Growth: Emphasize any potential for career advancement or skill development within the organization to attract candidates who are looking for long-term opportunities.

Leverage Clinical Research-Specific Platforms: Post job listings on platforms that specialize in healthcare and clinical research roles, such as those focused on clinical research associates, trial coordinators, and medical professionals, to access a broader pool of qualified candidates.

See why TemPositions

is the leader in staffing solutions.

Sample Interview Questions

• How do you ensure accuracy and thoroughness when collecting and analyzing clinical trial data?
• Describe your experience with clinical trial management software and electronic data capture systems. Which functions do you use most frequently?
• What strategies do you use to manage competing trial deadlines and prioritize tasks during high-demand periods?
• Can you share an example of a time when you identified a critical issue in a clinical trial? How did you address it?
• How do you stay organized when handling multiple clinical trials with varying patient populations and regulatory requirements?
• Describe a challenging clinical trial you worked on. What was your role, and what was the outcome?
• How do you ensure patient confidentiality and handle sensitive clinical trial data securely?
• In your opinion, what is the most complex aspect of clinical trials in your field, and how do you navigate it?
• How do you approach quality assurance in your work, particularly when managing clinical trial data and documentation?
• What steps do you take to stay updated on changes in clinical trial protocols, regulatory requirements, and industry best practices?

THREE EASY WAYS TO COMPLETE YOUR TEAM

TemPositions can assist you in finding the right fit for your team. Here are three ways to complete your team:

• Utilize TemPositions, a specialized staffing agency.
• Post your job on leading job boards.
• Leverage your professional network in the office sector. TemPositions offers access to a network of pre-screened and qualified professionals, saving time and ensuring you find the right fit for your team.

NEED HELP HIRING A Clinical Research Associate

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Clinical Research Associate Job Description, Duties, and Responsibilities

This post presents detailed information on the clinical research associate job description, including the key duties, tasks, and responsibilities they commonly perform.

It also highlights the major requirements you may be expected to meet to be hired for the clinical research associate role by most employers/recruiters.

What Does a Clinical Research Associate Do?

A clinical research associate is a healthcare professional who performs many activities related to medical research and clinical trials.

The clinical research associate job description entails monitoring clinical trials, working directly with the sponsor company as an independent freelancer or for a contract research organization.

They ensure compliance with clinical trials protocols, check clinical site activities, and communicate with clinical research coordinators.

Their role also ensures the protection of rights, safety and well being of human study subjects.

Research associates perform clinical trials to determine the effectiveness of drugs, their risk and benefits, to ensure that they are safe for public consumption.

Clinical trials may be carried out at various stages which involve trials on healthy humans and trials on patients with diseases to test its effect.

The clinical research associate’s work description also entails coordinating and processing results gained from long term testing of drugs, products, and medical procedures.

In addition to ensuring that trials stay on track with clinical objectives/federal regulations, research associates may analyze data, create reports, make presentations, monitor individual cases of test participants/family members, and use reference material to conduct additional research.

They also maintain databases of patient information, draft correspondence and gather data used in budgeting and granting proposals.

Clinical research associates are employed by pharmaceutical companies, scientific research organizations, academic institutions or government agencies.

To be hired for this job, you will need to have a Bachelor’s degree or postgraduate qualification in nursing, life sciences, or medical sciences.

The qualities to have to succeed on the job include excellent communication skills both written and spoken, ability to motivate others, numeracy, eye for details, good organizational, and administrative skills.

Clinical Research Associate Job Description Example/Template

Clinical research associates perform various functions in ensuring clinical trials conform to set objectives.

The job description example below highlights common duties, tasks, and responsibilities that make up the clinical research associate activities in most organizations:

• Develop and outline the purpose and methodology of trials
• Present trial protocols to a leading committee
• Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
• Identify and assess the suitability of facilities to be used at a clinical trial site
• Document site visits, issue reports, and follow-up letters to a site
• Visit trial sites on regular basis to conduct clinical trials on new drugs or medical procedures
• Monitor the trial throughout its duration
• Discuss results with a medical statistician who usually writes technical trial reports
• Respond to company, clients, and federal regulatory audits
• Contribute to the project team by sharing reasonable ideas and suggestions with them
• Monitor new members and assists in the preparation of project tools
• Archive study documentation and correspondence
• Prepare the final report and occasionally manuscript for publication.

Requirements – Skills, Abilities, and Knowledge – for Clinical Research Associate Job

Here are major requirements most employers will want you to meet to qualify for an interview if you are looking to work as a clinical research associate:

• Education and Training: To become a clinical research associate, you require a Bachelor’s degree in life science courses such as pharmacology, pharmacy, biochemistry, physiology, or toxicology. It may also be in a medical science field such as nursing, medicine, or dentistry. It is an advantage with some companies to have a relevant master’s degree in any of the above fields usually with at least an upper second class honors. It also requires experience in nursing, pharmacy, medical sales, and clinical laboratory work
• IT Skills: The clinical research associate requires good IT skills to be able to effectively apply computerized processes, including clinical trial management and electronic data capture systems to document and record information
• Communication Skill: Research associates should have excellent communication skills (both written and verbal) so as to be able to build effective relationships with trial center staff and colleagues
• Statistical Skill: They must be good problem-solvers with a solid understanding of scientific data collection and management methods.

If you are hiring for the clinical research associate job and need to make a good description to publish to attract the best candidates to your offer, you can apply the sample job description in this post to create one for your organization.

You will also find this post useful if you are interested in this career and desire to learn about it. The duties and responsibilities of the role highlighted in this article will certainly broaden your knowledge about it.

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The Job Description of a Clinical Research Associate

Clinical research associates are also referred to as CRAs. They are responsible for organizing and administering clinical trials of a current or new drug to assess and determine the risks and the benefits associated with using them. Clinical research associates are often employed by clinical contract agencies and pharmaceutical companies. There are many things that a clinical research associate needs to handle, and we will discuss them in this article.

Their responsibilities

The key responsibilities that a clinical research associate has to carry out in their course of duty include:

 Writing reports

 Progress monitoring during the trial duration

 Collection and authentication of forms that are used for data collection

 Giving the clinicians instructions about how trials are to be conducted

 Designing different trial materials as well as providing different study centers that have sufficient quantities

 Setting up the trial centers and then disbanding them

 Identifying the clinicians and briefing them

 Writing down the procedures of the drug trials

The employers

Typical employers include:

 The academic departments in hospitals

 Clinical contract houses and agencies (CROs)

 Pharmaceutical companies

Available vacancies are usually advertised in the national newspapers, online, specialist agencies, and very specific journals. This field is very competitive, therefore it can be useful for applicants to have the relevant analytical and scientific techniques. In addition, pharmaceutical research, medical sales, nursing, or laboratory work knowledge can be very useful in clinical research associate positions.

The process of recruitment involves an interview, which is very technical. You will need to be trained to get the kind of qualifications that are necessary to excel in this area. To achieve this, you need to be qualified in life sciences or medical sciences. To learn more about clinical research professional courses, visit CCRPS .

Unveiling the Role of Clinical Research Associates

Clinical Research Coordinator : Dive into the responsibilities and skills required for effective clinical research coordination.

Pharmacovigilance Certification : Explore the essential aspects of pharmacovigilance to ensure drug safety and regulatory compliance.

CRA (Clinical Research Associate) : Delve into the core responsibilities and duties of a Clinical Research Associate in managing clinical trials.

ICH-GCP : Understand the principles and guidelines outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP).

Clinical Trials Assistant Training : Acquire the foundational knowledge and skills necessary to support clinical trial operations effectively.

Advanced Clinical Research Project Manager Certification : Elevate your expertise in clinical research project management with advanced certification training.

Advanced Principal Investigator Physician Certification : Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies.

Medical Monitor Certification : Explore the critical role of medical monitoring in ensuring the safety and integrity of clinical trials.

Different Categories of Clinical Research Jobs Available as Careers

Understanding the scope of clinical research and what it entails.

• Job Descriptions
• Healthcare and Medical Job Descriptions

Clinical Research Associate Job Description

Clinical research associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs, and procedures. A clinical research associate, also known as a CRA, conducts research to ensure these products are safe to allow on the market.

Clinical Research Associate Job Description Template

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The clinical research associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. The clinical research associate will manage multiple aspects of the subjects' welfare. You will conduct regular site visits, generate and distribute internal and external newsletters, prepare final reports, and liaise with interested parties regarding all trial aspects. You will play a leading role in generating and overseeing documentation and records.

To be successful in this role, you should be able to recognize logistical problems and initiate appropriate solutions. Ideal candidates will be detail-oriented, have the ability to multitask, and be able to collaborate with various role players.

Clinical Research Associate Responsibilities:

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.

Clinical Research Associate Requirements:

• Bachelor’s degree in biological science or a related field.
• 2+ years of experience as a clinical research associate.
• Knowledge of the pharmaceutical industry, terminology, and practices.
• Knowledge of FDA regulations and their practical implementation.
• Strong verbal and written communication skills.
• Proficient computer skills.
• Proficient with Microsoft Office Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.
• Available to travel extensively and on short notice, and ability to manage travel schedules, such as flight schedules.
• Valid driver’s license, proficient driving skills, own reliable transport, and up-to-date car insurance.

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What is a Clinical Research Associate ?

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Clinical Research Associate Job Description Template

Job overview, clinical research associate responsibilities & duties.

• Monitor clinical trials to ensure compliance with the study protocol, Good Clinical Practice (GCP), and regulatory requirements
• Perform site selection, initiation, monitoring, and closure visits in accordance with study plans
• Review and verify case report forms (CRFs) for accuracy, completeness, and consistency with source documents
• Conduct source document verification to ensure data integrity
• Liaise between the sponsor and clinical trial sites to address issues and ensure smooth study progress
• Ensure timely reporting and resolution of adverse events
• Maintain up-to-date study documentation and records
• Assist in the preparation and submission of regulatory documents
• Provide training to site staff on the study protocol and best practices
• Ensure proper storage and handling of investigational products at clinical sites
• Foster strong relationships with site investigators and staff
• Prepare and present monitoring visit reports to the sponsor
• Assist in the development and review of study protocols and informed consent forms

Clinical Research Associate Qualifications & Skills

• Previous experience as a Clinical Research Associate or similar role
• Advanced degree in a related field, such as a Master's or PhD
• Familiarity with electronic data capture (EDC) systems
• Proficiency in multiple languages
• Experience working in various therapeutic areas
• Strong understanding of regulatory requirements and guidelines
• Certification from recognized clinical research organizations, such as SOCRA or ACRP
• Excellent communication and interpersonal skills
• Bachelor's degree in life sciences, health sciences, or a related field
• Minimum of 1-3 years of experience in clinical research or a related field
• Knowledge of clinical trial processes, GCP, and regulatory requirements
• Strong attention to detail and organizational skills
• Ability to work independently and manage multiple tasks effectively
• Excellent analytical and problem-solving abilities
• Proficiency with Microsoft Office Suite and clinical trial management systems (CTMS)
• Willingness to travel for site monitoring visits
• Strong written and verbal communication skills
• Ability to build and maintain strong working relationships with study sites and team members

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