Pavithra Kuppuraj

1. Conduct comprehensive site selection, initiation, interim monitoring, and close-out visits.

2. Document processes through detailed reports and follow-up correspondence.

3. Communicate project updates to internal teams and ensure timely completion of regulatory submissions.

4. Oversee the delivery of investigational products, Case Report Forms (CRFs), and laboratory supplies.

5. Ensure strict compliance with study protocols, ICH GCP guidelines, and FDA regulations.

6. Monitor safety events and escalate clinical site issues to project management.

7. Participate in quality assurance activities and effectively address audit findings.

8. Lead and engage in regular team meetings and teleconferences.

9. Trained in the development, compilation, and editing of medical documents.

10. Develop study protocols, non-interventional study reports, and investigator brochures in accordance with SOPs, timelines, and regulatory guidelines.

11. Conduct literature searches to support ongoing project initiatives.

12. Manage administrative tasks and oversee project timelines efficiently.

13. Conducted regular meetings with team members to discuss progress and identify areas for improvement.

14. Identified opportunities for process automation or streamlining existing procedures within the department.