1. To obtaining Inform Consent Form.
2. To request and maintain accountability of all study related documents.
3. To check all study related documents for its legibility, accuracy and completeness.
4. To solve QA/RGA queries.
5. To conduct study initiation meeting.
6. To supervise all ongoing study procedures including screening, check-in, dosing, blood collection and sample separation.
7. To do check-in and check-out of subjects.
8. To screen the subjects for participation in the Clinical Research study.
9. To prepare, issue and handle the identity cards of subjects.
10. To prepare and display study information details.
11. To supervise meal distribution.
12. To supervise water and posture restriction.
13. To participate in dosing procedure.
14. To Compile Trial Master File.
15. To operate and maintain breath alcohol analyzer.
16. To manage subjects during study.
17. To prepare study related labels.
18. Any other administrative or system related activities has assigned by the Head- Clinical or PI.
19.
To check the raw data before Quality Assurance check.
20. To monitor the Bio-Waste management.
21. To make Entry in CRF (Case record form).
22. To handle the IMP.
23. To participate in dosing procedure.
24. To prepare study related labels (for IMPs/Other).
25. Any other assigned work allotted by Group Leader/Head Clinical/PI.
26. Report any areas of concern they have relating to the quality system to their line manager, Directors, QAU-Head.
27. To prepare the work related SOPs (Standard Operating Procedures) and perform all activities as per SOP (Standard Operating Procedures).
Job Type: Full time Pay: ₹15,000.00 - ₹20,000.00 per month