Ec (Ethics Committee) Coordinator
4 days ago
**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).
Pay: ₹15,000.00 - ₹20,000.00 per month
**Benefits**:
- Health insurance
Schedule:
- Rotational shift
Work Location: In person
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