1. Project Planning & Support
- Assist in developing project plans, timelines, and trackers under guidance of Project Manager (PM).
- Help in preparing project
2. Regulatory & Ethics Compliance
- assist with submission packages to Ethics Committees
- Maintain and track approvals, amendments, and correspondence.
- Ensure compliance with ICH-GCP, SOPs, and local regulations.
- Follow up EC meeting and EC approvals
- Support collection and QC of essential documents (CVs, medical licenses, GCP training certificates, lab certifications, insurance)
3. Site Management Coordination
- Coordinate with site teams for collection of essential documents.
- Track site readiness, initiation status, and enrollment progress.
- Support CRAs in scheduling monitoring visits (SIV, IMV, COV).
- Ensure proper maintenance of Investigator Site Files (ISFs)
4. Cross-functional Coordination
- Work closely with CRAs, CTAs, Regulatory, and Finance teams.
- Report to the Project Manager and Senior Project Exceutive
- Coordinate investigator meetings, training sessions, and study calls.
- Assist in preparing meeting agendas, presentations, and minutes.
5. Data & Documentation
- Check document completeness and quality control.
- Assist with data entry and verification in project management systems
Job Types: Full-time, Fresher
Pay: ₹5,000.00 - ₹10,000.00 per month
Work Location: In person
