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Position: Clinical Subject Care Coordinator, Clinical Research

Location: Mumbai, Maharashtra

Job Description:

  • To monitor and perform Quality Check of all study activities from check-in, dosing, sample collection, processing, segregation, transfer, and till checkout.
  • Coordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.
  • Provide periodic review on the status of study files up to the archival of files.
  • Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.
  • Compilation of study data and review of clinical reports.
  • Coordinate with the Ethics Committee for submission of protocol and other study-related documents.
  • To perform QC of ICF, compensation chart, and review of CRF (versus Protocol), other study-related documents prior to EC submission.
  • To ensure that all the activities are performed by the delegated staff personnel in compliance with the EC approved protocol, GCP, and relevant SOPs and applicable regulatory requirements.
  • Handling of monitor’s visits, maintaining site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.
  • To carry out other responsibilities as and when assigned by the management.
  • Allocation of CRCs to studies on a monthly basis and providing guidance to the CRCs in conducting clinical trials.
  • Coordinate monthly review meetings with CRCs for the status of the studies and moderate QRM.

Qualification: B.Pharma, M.Pharma, M.Sc – Clinical Research

Experience: 8-10 Years as Clinical Research Coordinator

Salary: Negotiable

Contact Details:

Click here to Apply Now

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