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Position: Clinic Subject Care Coordinator I
Location: Navi Mumbai, Maharashtra
- 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.
- A retrospective review of study documents to ensure adherence to required SOPs and regulatory requirements. To ensure all appropriate entries after documentation.
- Any discrepancies/ Deviations to be informed to Team Leader and Manager (if required).
- Ensuring quality by reviewing all study-related documents like Regulatory binder, Raw data binders, Case Report Form binders, Study closeout report, Sample Case record form, Study updates, screening examination record.
- Full participation in internal and external audits by sponsors and other oversight entities such as FDA, EU, ANVISA.Review of SDTM & Clinic tables data with the source document. To verify the calibration and verification of instruments/equipment.
- To review the execution of the Qualification Protocol & Qualification Summary Report. To prepare & review standard operating procedures as delegated by PI or HOD or Manager.
- Ensuring quality by reviewing all study-related documents like Study Protocol and amendments, Informed consent form, Clinical Study Report, Electronic Trial master file, Study synopsis.
Qualification: B.Pharma, M.Pharma, M.Sc (Clinical Research)
Experience: 4-6 Years in Clinical Quality Control in Reputed BA/BE Center
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