The Clinical Research Coordinator (CRC) plays a pivotal role in the execution of clinical trials, working closely with principal investigators, sponsors, and other team members to ensure trials are conducted effectively, ethically, and in compliance with regulatory requirements. The CRC oversees various aspects of the research process, from participant recruitment to data collection and analysis.
Job Responsibilities:
1. Participant Recruitment and Informed Consent:
- Screen and identify eligible participants for clinical trials.
- Explain the study objectives, procedures, and risks to potential participants.
- Obtain informed consent from participants according to regulatory guidelines.
2. Study Coordination:
- Coordinate study visits and procedures for participants.
- Ensure adherence to the study protocol by all involved personnel.
- Schedule and facilitate meetings of the research team to progress the study project.
3. Data Collection and Management:
- Collect and record data accurately during study visits.
- Maintain organized and confidential participant files.
- Enter data into electronic databases and ensure data quality and integrity.
4. Regulatory Compliance:
- Ensure compliance with regulatory requirements, such as Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) regulations.
- Assist with the preparation and submission of regulatory documents.
5. Communication and Collaboration:
- Serve as the primary point of contact for study participants and their families.
- Communicate regularly with investigators, sponsors, and other stakeholders.
- Collaborate with other members of the research team, including nurses, physicians, and laboratory personnel.
6. Safety Monitoring:
- Monitor participant safety throughout the trial.
- Report adverse events and protocol deviations as required.
7. Study Close-Out:
- Assist with study close-out activities, including data analysis and final reporting.
- Follow up and manage accounts receivables.
- Ensure proper archiving of study documents and materials.
Qualifications:
- Bachelor’s/Master’s in a relevant field (e.g., Pharmacy, Nursing, Biology, Life Sciences).
- Prior experience of at least six months to one year in clinical trial site as CRC or related work is preferred.
- Strong organizational and interpersonal skills.
- Attention to detail and ability to follow protocols rigorously.
- Familiarity with regulatory requirements for clinical trials.
- Proficiency in computer applications, including electronic data capture systems.