Clinical Trails

Job Description:

Responsibilities

• 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.