Principal Investigator

16 hours ago


Ahmedabad, Gujarat, India Lambda Therapeutic Research Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Role & responsibilities

  1. Act as a Principal Investigator / Co-investigator in phase-1 studies, Biosimilar and BA/BE studies in all therapeutic area as well as various kind of formulation.

  2. Feasibility assessment of different molecules as per request from sponsors.

  3. Conducted complex BA/BE study at hospital site as Principal Investigator.

  4. Involved in Audit/Inspection handling and Projects conducted as Principal Investigator have been audited and cleared by different regulatory.

  5. Leading and guiding the Research Staff as Team Lead.

  6. Prepare and review protocols for clinical studies

  7. Ensure compliance to protocol, SOPs and Regulatory requirements

  8. Communicate IEC related issues to all concerned

  9. Coordinate with Project Coordinators for all project related matters

  10. Monitor and manage adverse events

  11. Coordinate with panel of consultants to seek medical opinion as and when required

  12. Ensure timely response to QA findings

  13. Interact with sponsors on medical related matters

  14. Handle safety related issues and ensure appropriate communication

  15. Prepare and review reports for clinical studies

  16. Overall supervision of screening and check-in activities

  17. Write and review related SOPs

  18. Contribute towards scientific development of the organization

  19. Support clinical trial group

  20. Handle medical confidential report and case management

  21. Help maintain and update all the systems and SOPs in the department

  22. Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs.

  23. Any other responsibilities as assigned by the Head of the Department



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