Job Description

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:

Health insurance
Work Location: In person