How you’ll spend your day
Co-ordinate with Project management Group (PMG) for compliance with the sponsor requirements and timelines.
Provide periodic review on status of study files up to archival of files.
Co-ordinate with Report Writing Group for the movement of files to the concerned department and ensuring to maintain timelines.
To monitor and perform Quality Check of screening and all study activities from check-in, dosing, sample collection, processing, segregation, transfer and till checkout.
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 SOP’s and applicable regulatory requirement.
Handling of monitor’s visits, maintaining of site visit log, resolution of all queries raised by the monitor/sponsor during his/ her site visit.
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 Manager (if Required).
Ensuring quality by reviewing all study related documents like ISF, Case Report Form binders, Study close out report, Sample Case record form, Study updates, medical screening record etc.
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 prepare & review standard operating procedures as delegated by PI or HOD or Manager.
Your experience and qualifications
M. Pharm
At least 12- 15 years of experience as a Quality Control in BABE Studies
