The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research studies in accordance with study protocols, ICH-GCP guidelines, regulatory requirements, and hospital policies. The CRC ensures smooth conduct of clinical trials by coordinating with investigators, sponsors, ethics committees, patients, and hospital departments while maintaining accurate documentation and ensuring participant safety.
- Coordinate all assigned clinical research studies from initiation to close-out.
- Screen, recruit, and enroll eligible study participants as per protocol.
- Explain study procedures and assist investigators in obtaining informed consent.
- Schedule participant visits and ensure protocol compliance.
- Coordinate study-related investigations, laboratory tests, imaging, and procedures.
- Maintain complete and accurate Trial Master Files (TMF), Investigator Site Files (ISF), and study documentation.
- Ensure timely and accurate completion of Case Report Forms (CRFs/eCRFs).
- Record and report Adverse Events (AEs) and Serious Adverse Events (SAEs) to investigators and sponsors within stipulated timelines.
- Coordinate with Institutional Ethics Committee (IEC), sponsors, CROs, and regulatory authorities.
- Prepare and maintain essential regulatory documents.
- Facilitate monitoring visits, audits, sponsor visits, and regulatory inspections.
- Ensure investigational product accountability in coordination with pharmacy.
- Track protocol deviations and implement corrective actions.
- Maintain participant confidentiality and data integrity.
- Prepare study progress reports and recruitment status reports.
- Coordinate study meetings and maintain communication with all stakeholders.
- Ensure compliance with ICH-GCP, CDSCO, NDCT Rules, and hospital SOPs.
- Support budget tracking and study-related documentation, if required.
