EC (Ethics Committee) Coordinator

Job Description

Administrative Coordination: Schedule Ethics Committee meetings and send timely notices to members. Prepare and circulate meeting agendas, study protocols, and supporting documents. Maintain records of EC member appointments and training. Documentation & Record-Keeping: Maintain an updated log of all submissions, approvals, and communications. Archive all documentation in accordance with regulatory guidelines (e.g., ICMR, CDSCO). Ensure timely filing of SAE (Serious Adverse Event) reports and protocol deviations. Regulatory Compliance: Ensure EC activities are compliant with ICMR guidelines, NDCT Rules 2019, and other applicable laws. Coordinate the submission of annual status reports, re-registrations, and accreditations. Communication & Liaison: Act as a liaison between investigators, sponsors, and the Ethics Committee. Communicate EC decisions to investigators in a timely and documented manner. Meeting Management: Coordinate quorum and attendance during meetings. Assist in drafting and finalizing meeting minutes and decisions. Follow up on action items and pending reviews. Training and Capacity Building: Organize training for EC members and maintain training logs. Stay updated on evolving regulatory and ethical standards. Qualifications: Bachelor’s degree in Life Sciences, Healthcare, or related field (Master’s preferred). Certification in Clinical Research / GCP is an added advantage. At least 1–3 years of relevant experience in Ethics Committee or clinical research coordination. Key Skills: Knowledge of GCP, ICMR, and regulatory guidelines. Strong organizational and documentation skills. Effective communication and interpersonal skills. Attention to detail and confidentiality. Proficiency in MS Office tools (Word, Excel, PowerPoint). Job Type: Full-time Pay: ₹15,000.00 - ₹20,000.00 per month Benefits: Health insurance Schedule: Rotational shift Work Location: In person