Clinical Research Coordinator - II

P D Hinduja Hospital and Medical Research Centre (HNH); Mumbai; On-site; INR 600,000 - 800,000; Full time

Job summary

P D Hinduja Hospital and Medical Research Centre (HNH) in Mumbai seeks a Clinical Research Coordinator to oversee coordinated activities between Sponsor, Principal Investigator and Ethics Committee, ensuring timely consent and submission of all trial documentation.

The role includes coordinating site initiation visits, monitoring, IP handling, SAE reporting, data queries, and archival of trial records, with close collaboration with the Research department and Director Research.

Responsibilities

• Overall coordination between Sponsor, PI, and Ethics committee. Assistance in consenting and maintaining all paperwork related to the trial. Timely submission of trial related documents.
• Coordinate various activities for trial initiation working closely with the sponsor/ CRO/ PI and Research department.
• Ensure timely and complete submission of research proposal, budget and other documents (as per checklist) related to the trial for IEC review. Review documents prior to submission.
• Coordinating site initiation visits/site evaluation/ monitoring visits / and site closeouts.
• Assist in scheduling of patient visits in coordination with PI & CRC and ensure their follow up.
• Ensure CRF / eCRF completion.
• Facilitate investigational product (IP) storage and handling as per protocol.
• Maintain temperature log of investigational product (if indicated).
• Maintain patient screening and other required logs.
• Ensure Serious Adverse Events (SAE) reporting as per protocol (intimation to authorities as per CDSCO timelines).
• Report patient withdrawal update regularly to Research department.
• Submit trial related records and documents to research department for archival.

Job description

1. Overall coordination between Sponsor, PI, and Ethics committee. Assistance in consenting and maintaining all paperwork related to the trial. Timely submission of trial related documents.
2. Report to the concerned PI and Director - Research.
3. Coordinate various activities for trial initiation working closely with the sponsor/ CRO/ PI and Research department.
4. Ensure timely and complete submission of research proposal, budget and other documents (as per checklist) related to the trial for IEC review. Review documents prior to submission.
5. Ensure that highlighted copies of documents are submitted as and when necessary.
6. Ensure adherences to quality assurance.
7. Effectively communicate with PI, EC, and sponsor and coordinate activities related to approvals / correspondence / submissions / amendments/ notifications by keeping track of the same.
8. Coordinating site initiation visits/site evaluation/ monitoring visits / and site closeouts.
9. Assist in scheduling of patient visits in coordination with PI & CRC and ensure their follow up.
10. Ensure CRF / eCRF completion.
11. Facilitate investigational product (IP) storage and handling as per protocol.
12. Maintain temperature log of investigational product (if indicated).
13. Maintain patient screening and other required logs.
14. Ensure Serious Adverse Events (SAE) reporting as per protocol (intimation to authorities as per CDSCO timelines).
15. Report patient withdrawal update regularly to Research department.
16. Collect approved investigation vouchers from research department.
17. Ensure sample collection and its dispatch in coordination with the concerned study staff and sponsor / CRO.
18. Submit receipts/bills of investigation/patient travel allowance/ SAE vouchers etc. to research department in a timely manner. Coordinate with clinical research officer - trial operations.
19. Facilitate resolution of data queries in coordinating with PI and RF.
20. Ensure timely submission of safety reports.
21. Ensure periodic submission of progress reports to EC.
22. Complete study closure related documentation.
23. Submit trial related records and documents to research department for archival.
24. Any other trial related responsibilities assigned by the PI or Director Research.
25. Any other duty assigned by Director Research and required in the department.