clinical trial research job description

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What is a Clinical Researcher ?

Clinical Researchers are responsible for designing and conducting clinical trials to test the safety and efficacy of new drugs, medical devices, and treatments. They work with teams of scientists and medical professionals to develop protocols, recruit participants, and collect and analyze data. They also play a critical role in the development of new medical treatments and the advancement of medical knowledge. Clinical Researchers may work for pharmaceutical companies, medical device manufacturers, academic medical centers, or research organizations.

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Clinical Researcher Job Description Template

Job overview.

We are seeking a highly motivated and experienced Clinical Researcher to join our team and contribute to advancing the field of medical research. As a Clinical Researcher, you will play a critical role in conducting studies and trials to determine the safety and effectiveness of new treatments and medications. The successful candidate will be a detail-oriented individual with excellent communication and organizational skills, and a passion for making a difference in people's lives.

Clinical Researcher Responsibilities & Duties

• Design, plan, and implement clinical trials and research studies.
• Collect and analyze data from clinical trials and research studies.
• Prepare reports, publications, and presentations to share results and findings with colleagues, stakeholders, and the general public.
• Maintain accurate and detailed records of all research activities.
• Ensure that all research activities are conducted in compliance with ethical, legal, and regulatory requirements.
• Collaborate with cross-functional teams, including physicians, scientists, and regulatory specialists.
• Stay up-to-date with current trends and advancements in the field of clinical research.

Clinical Researcher Qualifications & Skills

• Previous experience in a leadership role in clinical research.
• Publication record in peer-reviewed journals.
• Knowledge of current trends and advancements in the field of clinical research.
• Strong network of professional contacts in the field of clinical research.
• Master's or PhD degree in a relevant field, such as medicine, biology, or public health.
• 3-5 years of experience in clinical research or a related field.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects and deadlines effectively.
• Strong attention to detail and accuracy in record-keeping.
• Experience with data analysis and statistical methods.
• Familiarity with regulatory requirements for clinical research.

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• Clinical Research Coordinator Roles and Responsibilities

Position Role Sponsored Program Administration Financial Management Effort Reporting Conflicts of Interest Human Research Participant Protection Environmental Health and Safety Human Gene Transfer Export Controls

Position Role

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

The clinical research coordinator reports primarily to the Principal Investigator with associated responsibilities to the department head, division administrator or program administrator.

Sponsored Program Administration

General administrative.

• Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to)  protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.

Preparation of Scientific Proposal

• Assists the PI in study feasibility assessments as requested.

Proposal Budget

• Collaborates with the PI and department to prepare a categorized budget and justification. Confirms accuracy and completeness of budgeted costs.

Protocol Preparation & Review

• Reviews and comprehends the protocol.
• Attends investigator meetings as required or requested by the PI.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol.
• Prepares other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

Conduct of Research

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Registers participants to the appropriate coordinating center (if multi-site study).
• Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.
• Coordinates participant tests and procedures.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Maintains study timelines.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Retains all study records in accordance with sponsor requirements and university policies and procedures.
• Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.
• Assists PI in preparation of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management.
• Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.

Project Closeout

• Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable federal agencies, university entities, and the sponsoring agency in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Arranges secure storage of study documents that will be maintained according to university policy or for the contracted length of time, whichever is longer.

Financial Management

• Reviews and accepts/corrects the billing matrix as set up by the Center for Applied Research Science (CARS) to facilitate billing of study procedures to the appropriate research fund.
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with university policies and procedures.

Effort Reporting

• Reviews, adjusts and legally certifies personnel activity reports if applicable. Completes effort reporting certification within the timeframe specified by Sponsored Project Accounting.

Conflicts of Interest

• Takes appropriate steps to avoid conflicts of interest, or the appearance of conflicts of interest, between financial or other personal interests and the goals and policies of the university.
• Complies with applicable school, university, and sponsoring agency conflict of interest policies and procedures. Discloses all financial conflicts of interest to the appropriate supervisor.
• Cooperates with university compliance and monitoring efforts related to conflicts of interest and reports instances of noncompliance to the appropriate compliance office.

Human Research Participant Protection

• Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations. Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Informed Consent

• Assists in preparation of all documents related to the informed consent process.
• Assists Principal Investigator in preparation and submission of informed consent documents to HRPO for review and approval.
• Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Collects data as required by the protocol. Assures timely completion of Case Report Forms.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Retains all study records in accordance with sponsor requirements and University policies and procedures.
• Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

Protected Health Information

• Adheres to and supports all Federal regulations and University policies and procedures instituted to safeguard protected health information (PHI).
• Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.
• Cooperates with University compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems

• Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO (Washington University’s IRB).
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists in the registration (if required) of the study at ClinicalTrials.gov and maintains current information on the site.
• Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.

Environmental Health and Safety

• Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have completed required environmental health and safety training in accordance with federal, state, and local regulations and university and sponsoring agency policies and procedures.
• Works with Environmental Health and Safety to ensure that all facilities used are in compliance with all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.

Human Gene Transfer

• Assists Principal Investigator in assuring that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with Federal regulations and University and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to)  protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Cooperates with University compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and/or sponsors.
• Cooperates with University and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested by the PI. These study materials include but are not limited to the informed consent documents, case report forms (CRFs), enrollment logs, and drug/device accountability logs.
• Engages participants in the informed consent process according to the HRPO approved process.

Award Acceptance (Terms & Conditions)

• Reviews and develops a familiarity with the contract or award terms and conditions.  Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor and/or Washington University Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintains study files in accordance with sponsor requirements and university policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
• Adheres to and supports all federal regulations and university policies and procedures instituted to safeguard protected health information (PHI).
• Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with federal regulations and university and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.
• Cooperates with university compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.
• Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

Export Controls

• Develops awareness of export control regulations and complies as appropriate.

Revised January 2009 | Created 2007

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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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Biochemist job description, chemical engineer job description, clinical research associate interview questions, biochemist interview questions, chemical engineer interview questions, clinical research associate resume.

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Clinical Trial Associate Job Description

Clinical trial associate duties & responsibilities.

To write an effective clinical trial associate job description, begin by listing detailed duties, responsibilities and expectations. We have included clinical trial associate job description templates that you can modify and use.

Sample responsibilities for this position include:

Clinical Trial Associate Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Clinical Trial Associate

List any licenses or certifications required by the position: CCRP, CCRC, CCRA, APICS

Education for Clinical Trial Associate

Typically a job would require a certain level of education.

Employers hiring for the clinical trial associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Associate Degree in Science, Health, Life Sciences, Education, Healthcare, Nursing, Life Science, Medical, Pharmacy, Associates

Skills for Clinical Trial Associate

Desired skills for clinical trial associate include:

Desired experience for clinical trial associate includes:

Clinical Trial Associate Examples

• Microsoft Word (.docx) .DOCX
• PDF Document (.pdf) .PDF
• Image File (.png) .PNG
• Raise alerts where current status of data quality or performance is at risk to achieving business goals
• Serve as lead on IT projects around automation of reports or development of tools to aid/ drive process improvement as appropriate
• Support related systems as acting subject matter expert to SharePoint, Metrixx, Vantage, Compass, IMPACT, iDASH
• Oversee quality control of reports/tools functionality
• Provide support to both the Field Monitoring and Project Management Organizations
• Support ClinAdmin data entry and maintenance of country, site and patient visit level data as needed
• Identifying and ensuring strategies, resources, and accountabilities are in place to achieve rapid, high quality execution of assigned clinical studies under his/her responsibilities
• Managing all activities of assigned clinical studies within the Clinical R&D Operations group
• Functioning as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Evaluating support requests for publications and to provide consolidated comments and support to the requests
• Managing Resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Tracking assigned projects budgets to ensure adherence to business plans
• Supporting the implementation of new clinical systems/processes, and provide support for publications, as needed
• Interfacing and collaborating with investigators, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Providing quality feedback to the Directors and Managers on each resource assigned to clinical studies regarding performance within the context of the clinical studies
• Assist with ensuring sponsored project and fellowship proposals and awards are complete, contain accurate budgets, and meet university compliance
• Basic understanding of applicable federal regulations, sponsor requirements, and University policies such as OMB A-21, OMB A-110, Cost Accounting Standards, Food and Drug Administration and Medicare pricing and reimbursements
• Conduct a preliminary review of sponsor awards for consistency with proposal request
• Provide administrative support to the CTRPM on progress and final reports
• Work with University and School of Medicine central offices to facilitate the pre- and post-award processes
• Working knowledge of University systems such as SeRA, eProtocol, Oncore
• Assist CTRPM with data collection and data integrity in the SeRA system
• Supports Clinical Biometrics in coordination of receipt of all ancillary data safety lab data, analytic lab data, IVRS randomization data to ensure data is received at the time of database lock
• Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines
• Acting as Global Regulatory Leader for designated clinical trials in liaison with internal and external partners
• Development of global submission strategies for clinical trials
• Able to communicate ideas and concepts clearly in both written and oral form
• Frequently perform desk based computer tasks, seated work, use a telephone and use light/ fine grasping
• Occasionally write by hand, lift, carry, push pull objects that weigh up to 10 pounds
• Rarely stand, walk, sort, and file paperwork or parts
• Contacting external and internal individuals
• You will possess sufficient administrative experience within a busy environment where you have demonstrated excellent organisation and prioritization skills or hold a bachelor’s degree in a science related field
• Provide technical oversight of the compilation, review and release of applications for clinical trials in compliance with regulatory requirements internal guidelines
• Conduct reviews of key technical study documents to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents and ease of review
• Design and complete regulatory deliverables for designated projects
• Provide regulatory advice to project teams
• Manage life-cycle of designated studies post approval
• Keeping up-to-date with regulatory requirements
• Provide modeling and CTS supports to clinical trial design, drug development planning, licensing candidates evaluation, and critical post-marketing commitments to guide decision making
• Provide modeling and CTS support for regulatory filings and/or in response to regulatory requests
• Closely collaborate with project teams consisting of members of different functions
• Perform related modeling and clinical trial simulations, in addition to any required methodology research
• Minimum 0-2 year's experience in relevant field (eg
• Demonstrated ability to meet long and short-term deadlines with accuracy
• You will be fluent in English and the local language for the country you are applying
• Fluency in English is a must (any additional European languages are a plus)
• Minimum of a Bachelor's Degree in Life Sciences or Pharmacy, Advanced Degree Preferred
• At least fluent vocal and written English and Romanian
• Reviews study start up documents and disseminates to the appropriate functional groups
• Maintains study specific timelines, and provides information as needed to the study team
• Escalates non-standard problems or issues as may be required
• Preparing essential clinical trial documentation, distributing, tracking and filing of documents
• Identifies potential issues and suggests resolutions
• Maintains ongoing contact and communication with the clinical teams
• Prepares CTA submission to Health Canada and France
• To prepare and coordinate of regulatory deliverables for assigned projects in Canada and France, including close cooperation with regulatory authorities
• To act as local regulatory contact and regulatory lead for assigned studies (France)
• You may act as a Regulatory Project Lead on small clinical research projects
• PhD in quantitative sciences including statistics, biostatistics, engineering, mathematics, computational science, or a field with significant modeling-related content is preferred
• 4+ years of experiences in pharmaceutical industry and clinical trial knowledge are preferred
• A degree in Life Sciences
• Regulatory experience with Clinical Trials
• Previous experience in Regulatory Affairs and Clinical Research
• Experience in clinical study start-up
• Register and maintain trial information on public websites
• Customize/update any portfolio level plans or process flows to the study/ site level in collaboration with the CPLs and the CRO teams, as appropriate such TMF Plan, site training plan, site monitoring plan, cross functional data review plan, IP release documentation collection plan
• Serve as a system expert for the implementation of any business technologies that are operational in a study/franchise throughout the study’s life cycle
• Generate and maintain study essential documents checklist, IP release documentation and proactively ensure study document submission to the eTMF throughout the study’s life cycle
• Coordinate study team training in the investigator portal
• Deliver CRA training at KOM on business technologies/applications that are operational in a study
• Responsible for ensuring registration of a protocol in ClinTrials.gov and monitor its update throughout a study’s life cycle for compliance with the regulations and SOP
• Participate in sponsor operational team meetings with the CRO, Data Management, Regulatory Affairs, CQA and Clinical Supplies and document escalations and actions around training, TMF, IP release Clinical Trial Registry documentation
• Participate as a SME in the implementation of various Clinical Operations initiatives in conjunction with the CoE as required
• Monitors the status of start-up timelines for new studies including IRB approval and contract execution
• She/he has worked already in an international environment or CRO
• Minimum of a Bachelor's Degree in Life Sciences or Pharmacy, Advanced Degree strongly preferred
• 3-5 years of experience in Regulatory Affairs and Clinical Research
• Bachelor’s degree and 5-7 years relevant industry
• Fluency in English is a must along with the local language
• Problem solving abilities, troubleshooting and resourcefulness

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Home > Resources > Healthcare Analytics > Clinical Research Manager Job Description

Clinical Research Manager Job Description

• Published July 26, 2017
• Updated May 2, 2024

Clinical research managers hold one of the most critical jobs in the healthcare industry, overseeing all aspects of clinical trials that evaluate new medications and medical devices.

People in these positions carry the responsibility for making sure the trial is conducted under very strict, very specific guidelines.

The job carries a great deal of responsibility. Clinical trials are a vital part of the development of any new medication or medical device, and companies often have their future riding on the outcome. Clinical trial managers not only oversee the trial, but also act as liaison between the trial site and the clinical study sponsor.

It’s a difficult job, but one that can provide a rewarding, stable and often lucrative career.

What Clinical Research Managers Do

When a company develops a new healthcare product, they must meet government regulations before being allowed to sell their product on the market. This means conducting clinical trials that determine whether the product does what its developers say it’s going to do, as well as ensuring that the product is safe for use.

Clinical research managers have a variety of duties associated with such trials. They include:

• Planning and overseeing the trial
• Determining whether a product accomplishes the goal for which it was produced
• Ensuring the product meets all government regulations and standards
• Managing a team of clinical research associates and specialists
• Training clinical research team members and evaluating their performance

In addition, clinical research managers communicate with trial sponsors, keeping them updated on progress.

Skills and Education Needed

Working as a clinical research manager requires a mix of skills. They include leadership in guiding the research team, communication skills with both the team and study sponsors, as well as the technical skills needed to successfully plan and execute a clinical trial.

The people in this field come from various backgrounds. They typically have at least a bachelor’s degree in a field related to their clinical work, ranging from biology to life sciences and bioengineering. Attaining the manager position almost always requires a master’s degree or doctorate.

The ability to write study protocols and other research-related documents is key, as is expert-level knowledge in clinical trial practices and regulations. Project management skills also can prove beneficial for clinical research managers, given the complexity of the job and requirement to lead cross-functional teams.

Typically, those who become research managers also have years of experience at lower levels of the operation, including research specialists.

*National long-term projections may not reflect local and/or short-term economic or job conditions, and do not guarantee actual job growth. Information provided is not intended to represent a complete list of hiring companies or job titles, and program options do not guarantee career or salary outcomes. Students should conduct independent research for specific employment information.

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Clinical Research Associate Job Description

Clinical research associates (CRAs) are responsible for organizing and administering clinical research trials for new or current drugs so that they may assess the risks and benefits of using them. The major responsibilities of clinical research associate jobs are:

They write out the procedures for administering drug trials.

They identify and brief appropriate trial investigators.

They make use of their knowledge of the basics of clinical research to collect and analyze and record data.

They design trail materials and supply the research study centers with the quantities that they need.

They monitor the process of the trial from the start to the finish.

Clinical research associates are always present in the institute of clinical research because of the essential duties that they perform. However, the position is very competitive according to various job websites. As competitive as it is, it is also lucrative. Clinical research associate can work in government clinical research institute , pharmaceutical companies, private owned clinical research institute , etc. Their salaries may differ based on how much the individual companies or employees offer at their different choice of work place. But on the average, clinical research associates are paid around $65,000 per year. This leaves the pay at about $24 - $25 per hour.

There are various factors that can affect how much a clinical research associate (CRA) goes home with at the end of the month or cumulatively at the end of the year. These factors can be the location of the company, that is, the economic strength of the country or city where they are working, the degree or certificate or the level of education and exposure that the CRA has, the number of years if working experience that they have accumulated. These factors work together to determine how much they take home.

You can boost your chances of getting a higher pay, in the region of $85,000 to $90,000 or even more by getting the necessary education and certification. For example, experienced contract CRAs can earn up to $300k .

Skills required to be successful as a clinical research associates include:

A logical and inquisitive mindset with quick thinking.

Good organizational abilities.

Excellent communication skills. Both written and verbal are important.

Commercial awareness.

The basic requirement to be a clinical research associate is an undergraduate degree or a postgraduate degree in related life sciences fields (like biology, toxicology, microbiology, pharmacology, biochemistry), nursing, or medical sciences (like immunology, pharmacy, anatomy, physiology, or medicine). Due to the competitive nature of the job, some people go ahead and obtain a doctorate degree in any of the above mentioned fields. This gives them a better chance of getting a senior level job and increase their promotion prospect.

Beyond academic degrees, you need to be certified to become a clinical research associate. You need certification from organizations like ACRP (association of clinical research professionals) or SOCRA (society of clinical research associates). You will need to obtain certification course and pass the exams to become certified. At ccrps.org , we offer ACCRE accredited courses and insider information on everything you need to know for a career in clinical research. You can click here to see the offers for the courses available.

Take courses from CCRPS and learn more on how to become a clinical research professional:

Clinical Research Coordinator

Pharmacovigilance Certification

Clinical Trials Assistant Training

Advanced Clinical Research Project Manager Certification

Advanced Principal Investigator Physician Certification

Medical Monitor Certification

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

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Home // Clinical Research Associate

Clinical Research Associate

What does a clinical research associate do.

As a Clinical Research Associate (CRA) in clinical operations you are responsible for setting up, coordinating and supervising clinical studies. You plan, prepare and help carry out clinical trials to test new or existing investigational products. This assesses their safety and benefits of use. The work is usually done within pharmaceutical companies or CROs who conduct clinical research on behalf of pharmaceutical companies. Studies are also required within hospital departments that collect information about investigational products.

You are the primary contact for various parties including doctors, researchers, laboratories, pharmacists, ethics committees and others such as the sponsor (usually a pharmaceutical company) or client. In summary, as a CRA you are responsible for ensuring that all the risks and effects of investigational products have been fully examined and approved, prior to their release on the market.

Curious about other clinical jobs? Take a look at clinical trial assistant or clinical project manager . Looking for a starters job? Take a look at starters for the life sciences !

Take a look at the Clinical Research Associate vacancies to see which are the best fit for you!

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What responsibilities can you expect as a Clinical Research Associate?

The CRA position is diverse and dynamic. Specific duties can vary depending on the company and you may work on multiple projects. A CRA will generally be required to:

• carry out selection, initiation, monitoring and close-out visits at the participating clinical trial centres, also for logistics and coordination of the study;
• monitor the study to check whether it has been carried out in accordance with applicable laws and regulations;
• develop study procedures, methodology and instructions for clinical trials staff, as well as design data collection tools (case report forms);
• manage study supplies, medication supplies and medication accountability;
• collect, verify and finalise collected data to create reports and present results of findings to other medical staff;
• ensure the safety and well-being of test subjects by liaising with ethics committees;
• submission of clinical trial documents for review and approval by those ethics committees.

Some travel may be required, depending on the terms of the job.

What education and skills do you need as a Clinical Research Associate?

Some of the CRA qualifications and skills must be relevant to the pharma industry. For example, a Clinical Research Associate needs to have a degree in a Life Science*. In summary, you need to have these qualifications, knowledge and personal attributes:

• completed bachelor or masters degree, or a PhD in a Life Science;
• driver’s licence;
• excellent computer skills;
• excellent communication and organisational skills;
• flexible, accurate working and a high level of integrity;
• knowledge of good clinical practice (GCP) with relevant training is an advantage (and conditional on the job itself).

*Relevant subjects include biology, microbiology, medicine, pharmacology, pharmacy, molecular biology, toxicology and immunology.

If you have done some work within a hospital, pharmaceutical company or CRO that would be a bonus.

You should also have knowledge of international guidelines as well as good distribution and manufacturing practice. Employers may expect you to have an understanding of how clinical study management works. This includes monitoring, study investigational product handling and data management. You should also be familiar with the area of medicine or science where you are applying, such as oncology or haematology.

What salary can you expect as a Clinical Research Associate?

CRA jobs in the Netherlands usually offer a salary ranging from € 35.000,- to € 55.000,- a year. This all depends on location, experience and the type of company. A lease car may also be offered. In a Senior Clinical Research Associates role the salary can rise to € 75.000,-. There may also be Contract Clinical Research jobs available, with different terms and salaries.

Do you want to know more about positions as a Clinical Research Associate?

Clinical Research Associate is a position within Clinical Operations . To conduct clinical research, a position within Clinical Operations such as CRA is essential.

See all Clinical Research vacancies

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Clinical Trial Assistant Job Description [Updated for 2024]

In the world of healthcare, the role of a Clinical Trial Assistant has never been more crucial.

As medical research progresses, the demand for dedicated individuals who can coordinate, monitor, and ensure the smooth execution of clinical trials increases exponentially.

But let’s delve deeper: What’s truly expected from a Clinical Trial Assistant?

Whether you are:

• A job seeker trying to understand the core responsibilities of this role,
• A hiring manager crafting the ideal candidate profile,
• Or simply intrigued by the intricacies of clinical trials,

You’re in the right place.

Today, we present a comprehensive Clinical Trial Assistant job description template, tailor-made for easy posting on job boards or career sites.

Let’s dive right into it.

Clinical Trial Assistant Duties and Responsibilities

Clinical Trial Assistants support the clinical trial process, ensuring that every step is executed according to regulatory standards and protocol.

They also handle administrative duties and liaise with team members and clinical trial participants.

Key duties and responsibilities include:

• Assisting in the planning and implementation of clinical trials
• Organizing and maintaining all clinical trial documentation and records
• Ensuring that all necessary trial materials and supplies are in stock and properly accounted for
• Liaising with investigators, trial participants, and sponsors
• Assisting with participant recruitment and enrollment
• Performing data entry and managing databases for the trial
• Ensuring all trial activities are conducted in accordance with the protocol and regulatory requirements
• Assisting with the preparation of reports and other clinical documents
• Monitoring trial progress and reporting any issues or concerns
• Coordinating and scheduling trial activities and meetings

Clinical Trial Assistant Job Description Template

We are searching for a detail-oriented and highly organized Clinical Trial Assistant to join our research team.

The Clinical Trial Assistant will support the Clinical Trial Manager and the clinical research team in executing clinical trial activities, managing trial data and maintaining trial documentation.

The successful candidate will have an understanding of Good Clinical Practices (GCP), and the ability to work collaboratively in a fast-paced clinical environment.

Responsibilities

• Assist in the organization and planning of clinical trials
• Prepare, handle, distribute, file, and archive clinical documentation and reports
• Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
• Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
• Coordinate and manage logistical aspects of clinical trials, such as shipment of supplies
• Assist in the preparation of regulatory submissions
• Maintain a system for tracking and scheduling patient visits
• Ensure all study materials are properly archived following the completion of a trial

Qualifications

• Proven work experience as a Clinical Trial Assistant
• Understanding of medical and pharmacological terminology
• Knowledge of Good Clinical Practice (GCP) guidelines
• Strong organizational and planning skills
• Excellent communication and interpersonal skills
• Proficiency in database management and latest office technology
• BSc degree in life sciences or related field
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

Additional Information

• Job Title: Clinical Trial Assistant
• Work Environment: Clinical or office setting. Some travel may be required for trial site visits or meetings.
• Reporting Structure: Reports to the Clinical Trial Manager.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $48,000 minimum to $75,000 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 Trial Assistant Do?

Clinical Trial Assistants work primarily for pharmaceutical companies, research institutions, and hospitals, playing a significant role in the clinical trial process.

They assist Clinical Trial Managers and Coordinators in conducting clinical trials by handling a variety of administrative tasks.

These duties may include organizing and maintaining trial documentation and plans, setting up trial sites, liaising with investigators, and tracking trial progress.

Clinical Trial Assistants are involved in the preparation, handling, distribution, and filing of clinical trial documentation.

This includes case report forms, consent forms, and other regulatory paperwork.

They often use specialized clinical trial management software to streamline these processes.

They also coordinate meetings, prepare meeting materials, and assist in the production of trial-related reports.

In some cases, they may be responsible for patient communication, scheduling, and assisting with patient recruitment for trials.

Accuracy and attention to detail are crucial in this role, as the data collected in clinical trials is used to determine the safety and effectiveness of new drugs or medical treatments.

Clinical Trial Assistants work closely with a team of professionals and must follow strict ethical guidelines and regulatory requirements to ensure the integrity of the trial data.

Clinical Trial Assistant Qualifications and Skills

A Clinical Trial Assistant should have the following qualifications and skills to effectively assist in clinical research and trials:

• Organizational skills to manage multiple clinical trials, track progress, and maintain detailed documentation.
• Scientific knowledge of medical terminology, clinical monitoring procedures, and Good Clinical Practice (GCP) principles.
• Excellent communication skills to liaise with trial subjects, clinical investigators, and other stakeholders, explaining trial protocols and clarifying any doubts.
• Proficiency in data management to accurately collect, analyze, and report trial data using specialized software.
• Strong attention to detail to ensure compliance with study protocols, ethical guidelines, and regulatory requirements.
• Problem-solving skills to identify and resolve issues that may affect the progress or integrity of clinical trials.
• Ability to work in a team-oriented environment, collaborating with clinical research coordinicians, investigators, and other healthcare professionals.
• Physical stamina to work long hours, if required, especially during critical phases of clinical trials.

Clinical Trial Assistant Experience Requirements

Entry-level Clinical Trial Assistants usually have at least 1-2 years of experience in a related field such as clinical research or healthcare.

This experience could be gained through internships or part-time roles.

Many Clinical Trial Assistants gain practical experience by working in a clinical research environment, assisting with tasks such as data collection, patient recruitment, and trial documentation.

Some may also have experience in a laboratory setting, which can provide valuable skills for this role.

Candidates with over 3 years of experience are likely to have developed their understanding of clinical trial processes, regulatory compliance, and data management.

They might have also gained experience in coordinating trial activities and ensuring that protocols are followed.

Those with over 5 years of experience are typically well-versed in all aspects of clinical trials and may be ready to take on more responsibilities, such as supervising junior staff or leading a trial team.

They may have also had the opportunity to work on a variety of different trials, thus broadening their knowledge and skills.

It is also worth noting that many employers prefer candidates who hold a degree in a relevant field, such as life sciences or nursing.

Additionally, certification from a recognized clinical research organization can significantly enhance job prospects.

Clinical Trial Assistant Education and Training Requirements

Clinical Trial Assistants typically require a bachelor’s degree in a life science or healthcare related field such as nursing, biology, or pharmacology.

In addition to their degree, they also need to have a solid understanding of medical terminology, clinical operations, and regulatory compliance.

Familiarity with clinical trial protocols, data management, and patient care are also essential.

For more advanced positions or those in specialized fields, some employers may require a master’s degree or equivalent experience in clinical research or a related field.

Clinical Trial Assistants may also be required to complete specific training programs or certifications to ensure they have the necessary skills and knowledge to manage clinical trials.

These could include Good Clinical Practice (GCP) certification, Certified Clinical Research Professional (CCRP) or Certified Clinical Research Associate (CCRA) credentials.

Continuous learning and staying updated on the latest clinical research developments and regulations is also essential in this role.

Work experience in a clinical or healthcare setting would be an added advantage for those pursuing a career as a Clinical Trial Assistant.

Clinical Trial Assistant Salary Expectations

A Clinical Trial Assistant earns an average salary of $48,787 (USD) per year.

However, this salary can fluctuate based on factors such as level of experience, educational qualifications, and the location of the job.

Additionally, the size and type of the organization can also have an impact on the salary.

Clinical Trial Assistant Job Description FAQs

What skills does a clinical trial assistant need.

A Clinical Trial Assistant should possess strong organizational and administrative skills, as they play a vital role in managing the documentation and regulatory records of clinical trials.

They should also have excellent communication skills to liaise effectively with other members of the clinical trial team.

Familiarity with medical terminology and clinical trial processes are essential, as well as proficiency in data management and the ability to handle multiple tasks simultaneously.

Do Clinical Trial Assistants need a degree?

Yes, a Clinical Trial Assistant typically needs a Bachelor’s degree in a field related to life sciences or health care.

Many employers also prefer candidates with prior experience in clinical trials or pharmaceutical research.

Additionally, a Clinical Trial Assistant should have knowledge of Good Clinical Practice (GCP) guidelines and other regulatory requirements related to clinical trials.

What should you look for in a Clinical Trial Assistant resume?

A Clinical Trial Assistant’s resume should demonstrate their experience in clinical research or related fields.

Look for skills in data management, regulatory compliance, patient recruitment, and document management.

Any experience in coordinating or assisting in clinical trials, interacting with study participants, or managing clinical trial data should also be highlighted.

Certifications such as a Certified Clinical Research Professional (CCRP) can be a plus.

What qualities make a good Clinical Trial Assistant?

A good Clinical Trial Assistant is meticulous and organized, as they are responsible for managing important trial documentation.

They have excellent attention to detail and are proficient in using various types of software for data management.

They also possess strong interpersonal skills, enabling effective communication with team members and trial participants.

Additionally, they should have a solid understanding of ethical and regulatory guidelines in clinical research.

What is the career progression for a Clinical Trial Assistant?

Career progression for a Clinical Trial Assistant may involve advancing to roles such as Clinical Trial Associate, Clinical Trial Manager, or Clinical Research Coordinator.

Some may also choose to specialize in specific areas of clinical research like data management or regulatory affairs.

Ongoing professional development and gaining extensive experience in clinical trials can open up more senior roles within the industry.

And there you have it.

Today, we’ve illuminated the pathway to understanding what being a Clinical Trial Assistant truly entails.

Surprising, isn’t it?

It’s not just about conducting trials.

It’s about shaping the future of medical research, one clinical trial at a time.

Equipped with our comprehensive Clinical Trial Assistant job description template and real-world examples, you’re ready to take the leap.

But why limit yourself?

Explore further with our job description generator . It’s your springboard to immaculately tailored job postings or refining your resume to the T.

Each clinical trial is a stepping stone towards a breakthrough.

Let’s usher in this new age of medical advancements. Together.

How to Become a Clinical Trial Assistant (Complete Guide)

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The Editorial Team at InterviewGuy.com is composed of certified interview coaches, seasoned HR professionals, and industry insiders. With decades of collective expertise and access to an unparalleled database of interview questions, we are dedicated to empowering job seekers. Our content meets real-time industry demands, ensuring readers receive timely, accurate, and actionable advice. We value our readers' insights and encourage feedback, corrections, and questions to maintain the highest level of accuracy and relevance.

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Hiring a Clinical Research Coordinator: Job Descriptions, Salary, and More

The clinical trial industry continues to grow as health and science research evolves and expand; There were already more trials in July 2023 (more than 450,000) than in all of 2022. With this increase in research, studies, and more comes the need to hire more skilled and trained professionals in this area.

Let’s take a look at what a clinical research coordinator is and all the pertinent details to know before recruiting and hiring this key role for your organization.

What is a Clinical Research Coordinator?

Clinical research coordinators (CRC) conduct the day-to-day activities of clinical trials and medical research. They work under the supervision of a principal investigator (PI) to ensure clinical trials and trial participants are operating safely and in compliance with local regulations and good clinical practice (GCP) .

Clinical Research Coordinator Roles and Responsibilities

The specific responsibilities of CRCs vary depending on the type of research being conducted and the needs of the PI. However, general roles and responsibilities include:

• Administrative duties such as documenting trial progress, scheduling patients, or performing data entry
• Adhering to Institutional Review Board (IRB) requirements and filing IRB submissions
• Liaising with clinical trial sites, conducting site training, and preparing site documents
• Managing communications between the research team, investigators, and sites
• Running and supporting patient visits, as well as obtaining informed consent and documenting patient activities

RELATED: Entry Level Healthcare Careers

Credentials of a Clinical Research Coordinator

Clinical research coordinators commonly have a bachelor’s degree in life sciences, healthcare, public health, or a related field. Some choose to pursue higher education or advanced credentials, such as CCRC (Certified Clinical Research Coordinator) , to better understand current trial procedures. And all candidates should feel comfortable in a clinical setting communicating directly with patients.

Top Skills of a Clinical Research Coordinator

Clinical research coordinators should understand the intricacies of clinical trials and the drug development process. They should also possess a combination of skillsets that assist them in the patient-facing and administrative aspects of the role.

The skillsets that best set up CRC candidates for success in their role include:

• Having a base-level understanding of lab procedures and clinical trial conduct
• Reliable computer skills for tracking clinical trial progress and conducting data entry
• Strong communication skills to liaise between teams and connect with trial patients
• Attention to detail with an ability to work under strict deadlines
• Empathy and compassionate care for patients participating in clinical research
• Ability to comprehend and execute specific clinical protocols
• Knowledge of local regulations and compliance standards
• Willing to learn and curious about analytics

Pay and Job Outlook

Staffing shortages are plaguing the entire clinical research industry, and clinical research coordinators are no exception. Rising pressures on clinical teams to produce more trials means that teams spend less time with patients and more time dealing with regulations, administrative tasks, and training.

Research by the Society for Clinical Research Sites (SCRS) found in 2022 that there were 5.7 million available CRC candidates and 6.6 million job listings for clinical research coordinators. For prospective candidates, this can be very promising as there is one CRC for every seven jobs posted. Hiring managers should consider this gap when considering salary and benefits offerings to entice top candidates.

As for pay, of the 2,400 listings studied by the SCRS in 2022, $82,000 was the median salary for a clinical research coordinator. Listings ranged from $40,000 to $120,000 depending on location, but SCRS noted an approximate 40-60% average salary increase, including retention bonuses and benefits, from before the pandemic.

Clinical Research Coordinator Job Description

Given the job landscape for CRCs, it’s important to create a clinical research coordinator job description that is clear and accurate to the role so you can attract the right candidates.

Be sure to include a thorough job summary that lists all of the clinical activities the individual will be responsible for. Highlight essential job functions that the individual will be performing daily, include who will supervise them, and note if they will be supervising others. Note if there are travel expectations and which teams this individual will be liaising between. And clarify if prior clinical experience is required or if the candidate should possess any specific training or certifications.

Finally, if the role requires specific physical requirements, be sure to outline them. This could include clinical trials that come into contact with sensitive materials or require a high physical requirement or occupational risk potential.

Commonly Asked Interview Questions for a Clinical Research Coordinator

When interviewing clinical research coordinator candidates, ask questions that highlight their hard and soft skills for the role, including:

• Share any prior clinical research experience you have. Have you previously worked on the administrative side, in the lab, patient-facing, or all three?
• Why did you choose to pursue a career in clinical research?
• How do you obtain informed consent from your trial patients? What steps do you take to ensure continuously informed consent through a trial?
• How do you stay up to date with clinical trial regulations and compliance?
• What health care or clinical trial software do you have familiarity with?
• What strategies do you use to meet tight deadlines or juggle competing priorities?
• How do you help patients understand medical terminology and trial protocols?
• What steps do you take to reduce patient dropouts during a trial?
• What strategies do you use to improve the diversity of your patient population?

Hire Your Next Clinical Research Coordinator Today

Clinical research coordinators are in high demand, so be intentional with your recruitment efforts. Ensure that your job description is comprehensive and accurate to what you expect the candidate to do and offer a competitive salary and benefits package.

If you need help accelerating your hiring efforts, reach out to a professional at Insight Global to kickstart your CRC recruitment today.

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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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Clinical Research Coordinator

Job description overview.

A Clinical Research Coordinator job description involves managing and overseeing clinical trials for medical research studies, pharma companies, and hospitals. They play a critical role in ensuring trials run smoothly by planning and coordinating logistics, providing guidance and support to the research team, and ensuring that study participants follow protocols. 

Clinical Research Coordinators will screen potential participants, schedule appointments, collect and analyze data, maintain study databases, and prepare regulatory documents. They are responsible for ensuring compliance with regulatory guidelines and procedures, managing budgets, and managing volunteers and other medical professionals. 

To be effective in this role, Clinical Research Coordinators need to have a strong attention to detail, excellent interpersonal communication skills, and the ability to multitask in a fast-paced environment. They should have a Bachelor's degree in a science-related field or equivalent experience, and be familiar with medical terminology, FDA regulations, and ethical considerations. 

Overall, a Clinical Research Coordinator job is an essential component of the science industry, providing a critical role in medical research and drug development.

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Table of contents, job duties and responsibilities.

• Coordinate the execution and management of clinical research studies.
• Ensure compliance with study protocols, regulations, and ethical standards.
• Recruit and screen research participants, and obtain informed consent.
• Collect, manage, and analyze data; maintain accurate records and documentation.
• Schedule and coordinate study visits, procedures, and tests.
• Communicate with study sponsors, investigators, and healthcare providers.
• Monitor study progress, identify potential issues, and implement corrective actions.
• Manage study-related finances, including budgets and reimbursements.
• Help disseminate study results and provide support for publication activities.

Experience and Education Requirements

To become a Clinical Research Coordinator in the Science industry, you will need a combination of education and experience. You will typically need a Bachelor's degree in a health-related field, such as nursing, biology, or chemistry. Sometimes, employers may require a Master's degree in a related field.  Additionally, you will need experience working with human subjects, either through volunteer work or previous job experiences. Often, employers prefer someone with at least two years of experience in the field. It is also important to have strong communication skills, organizational skills, attention to detail, and the ability to work well with a team. With the right combination of education and experience, you can pursue a career as a Clinical Research Coordinator in the Science industry.

Salary Range

Clinical research coordinators play a vital role in the science industry. Their job is to manage clinical trials from start to finish, ensuring all protocols are followed to the letter. If you're looking for information on the expected salary range for clinical research coordinators, you're in the right place. 

In the United States, clinical research coordinators can expect to make anywhere from $40,000 to $80,000 per year, depending on their level of experience and location. According to data from Payscale, the average salary for a clinical research coordinator is around $52,000 per year. 

Outside of the United States, clinical research coordinators can expect similar salaries. In Canada, for example, the average salary is around CAD$52,000 per year. Meanwhile, in the United Kingdom, clinical research coordinators can expect salaries ranging from £21,000 to £45,000 per year, depending on experience and location. 

Overall, clinical research coordinator salary range is relatively consistent across the globe. If you're interested in pursuing this career path, expect a decent salary with room for growth. 

• Payscale: https://www.payscale.com/research/US/Job=Clinical Research Coordinator/Salary
• Indeed: https://www.indeed.com/q-Clinical-Research-Coordinator-jobs.html
• SalaryExpert: https://www.salaryexpert.com/salary/job/clinical-research-coordinator/united-states

Career Outlook

The career outlook for Clinical Research Coordinators in the science industry over the next 5 years is expected to grow. According to the Bureau of Labor Statistics, job opportunities in this field are projected to increase by 4% from 2019 to 2029. This growth is due to an increasing demand for clinical trials in the medical and pharmaceutical industries.

Clinical Research Coordinators manage clinical trials, ensuring they are conducted safely, effectively, and in compliance with regulations. They work with physicians, pharmaceutical companies, and research institutions. Their role is critical in determining the effectiveness and safety of new drugs and treatments.

Overall, Clinical Research Coordinator is a promising field with opportunities for growth and career advancement. With the demand for clinical trials increasing, professionals with the knowledge and experience in this field will be in high demand.

Frequently Asked Questions (FAQ)

Q: What does a Clinical Research Coordinator do?

A: A Clinical Research Coordinator oversees clinical trials and studies. They work alongside the research team to organize and carry out the study, ensuring that all guidelines and safety measures are followed.

Q: What qualifications are required to become a Clinical Research Coordinator?

A: A minimum of a bachelor's degree in a scientific field and experience working in a medical setting is required. Additional certification in clinical research is also beneficial.

Q: Is traveling required for this job?

A: It depends on the study being conducted. Some studies may require travel, while others can be conducted entirely within a single location.

Q: What skills are important for a Clinical Research Coordinator?

A: Strong organizational and communication skills are essential, as well as an ability to manage a team of researchers, interact with study participants, and interpret complex data.

Q: What is the career growth potential for a Clinical Research Coordinator?

A: With experience, a Clinical Research Coordinator can advance to a Clinical Research Manager or Director position. Alternatively, they may choose to specialize in a particular area, such as pediatric or oncology research.

Job Descriptions:

Clinical laboratory scientist, biotech research associate, quality control analyst, microbiologist, analytical development scientist.