A Clinical Research Coordinator is a vital pillar of the research team in clinical studies. They conduct and manage clinical trials and help provide outcomes that can help advance medical science. Behind every successful Clinical Research study is a dedicated Clinical Research Coordinator. In this blog, we will discuss the important roles and responsibilities of a Clinical Research Coordinator.
Clinical Research Coordinator Roles and Responsibilities
There are various important roles and responsibilities in the clinical research coordinator job description.
1. Study Preparations
- Recruiting eligible participants.
- Training the site staff on the study protocol, GCP guidelines and other regulatory rules. Adhere to Good Clinical Practices.
- Screening and identifying potential participants for the trial.
- Contacting the participants to explain the study and assessing their eligibility to participate
- Assisting in setting the trial site.
2. Study Conduct
- Prepare and submit important documents for approval to the Institutional Review Board/Ethics Committee.
- Obtain informed consent from the eligible participants and explain to them the process.
- Ensure informed consent is obtained voluntarily and documented properly before any study procedure.
- Implement retention strategies to reduce dropouts.
- Connect the labs, diagnostics department for study conduct.
3. Patient Safety
- Monitor the participants and report adverse drug reactions or events if any.
- Ensure patient safety and well being
- Ensure patient safety data according to the legal regulations.
4. Data Management and Confidentiality
- Maintain trial master files and other confidential documents
- Collect data, maintain the accuracy of the data, schedule visits and coordinate with the participants.
- Maintain Case Report Forms or data in Electronic Data Capture systems and maintain data accuracy and safety.
- Clinical Research Coordinator responsibilities also include preparing important regulatory documents such as delegations, drug accountability, etc.
- Ensure all the important data is completed and submitted in their timelines.
5. Communication and Teamwork
- Coordinate and monitor audits and inspections.
- Collaborate with the team, sponsors,and help the Principal Investigator.
- Coordination investigational product management.
- Clinical Research Coordinator also has to assist with final reports, data lock, and study close-out activities.
- Attend regular meetings and provide important insights to the sponsors.
- Coordinate with the data management teams for queries resolutions and data lock.
The Importance of Clinical Research Coordinators
Clinical Research Coordinators are the backbone of the success of clinical trials. Without Clinical Research Coordinator expertise and dedication, the complex processes involved in conducting a clinical study would be significantly more challenging to navigate. These experts bring a wealth of knowledge and experience with them that allows the clinical research team to efficiently execute the clinical trial and achieve meaningful and helpful results.
FAQS about Clinical Research Coordinator Roles and Responsibilities
1. How to become a Clinical Research Coordinator?
A Degree such as a bachelor’s in Medicine, life science, nursing, physiotherapy, chemistry, biology etc, can pursue their career as a Clinical Research Coordinator, but switching careers can be overwhelming. A diploma course in clinical research will help you ace your career transition smoothly. CareerInPharma is the best clinical research training institute in India and offers the best clinical research diploma course that will help you achieve your dream job.
2. Which Companies hire Clinical Research Coordinators?
Top companies such as IQVIA, Parexel, ICON plc, Labcorp Drug Development (Covance), Syneos Health, Clario, Worldwide Clinical Trials, etc, hire Clinical Research Coordinators.
3. What is the average salary of Clinical Research Coordinators?
The Average salary of Clinical Research Coordinators ranges from 5 LPA to 13 LPA, depending on experience and the organisation.
4. What Skills are needed to become a Clinical Research Coordinator?
Skills such as detail-oriented, great communication, strong understanding of regulatory guidelines, staying updated about new research, teamwork work etc are required to become a Clinical Research Coordinator.
