- Assist in preparing, maintaining, and updating the Trial Master File (TMF/eTMF).
- Support with preparation, submission, and tracking of regulatory and ethics committee documents.
- Ensure proper filing, version control, and archival of essential study documents.
- Assist Project Managers and CRAs with study setup, feasibility, initiation, monitoring, and close-out activities.
- Track project progress through dashboards, trackers, and reports to ensure timelines and deliverables are met.
- Support with site payments, investigator communications, and vendor coordination.
- Manage shipment, distribution, and tracking of study supplies and clinical materials.
- Assist in maintaining investigator and vendor databases.
- Ensure that trial activities are compliant with SOPs, ICH-GCP, and local regulations.
- Support preparation for audits, inspections, and CAPA documentation.
- Assist in safety reporting documentation and SAE tracking.
- Participate in departmental initiatives and contribute to SOP development and process improvements.
- Gain hands-on experience to progress into CRA roles in the future.
Job Types: Full-time, Internship
Contract length: 6 months
Pay: ₹4,000.00 - ₹5,000.00 per month
Benefits:
Work Location: In person
