QC Reviewer-Clinic

1) Review of clinical raw data as per predefined Quality Control Plan for completeness, accuracy, and for compliance with the Study Protocol, GCP, SOPs and applicable regulatory Guidelines.

2) Online Monitoring of study activities to ensure that studies are conducted in accordance with GCP, SOPs, Protocol and applicable regulatory guidelines.

3) Issuance, Reconciliation and Accountability of Controlled forms / Documents as per applicable SOP.

4) Preparation of projects for QA audit and Archiving.

5) Review of Tabular listing appended to Clinical Study Report and Individual Subject CRF scan check (as applicable).

6) Assist QC in-charge in review of Quality Control- Clinic SOPs.

7) Any additional responsibility given by Head of the Department / Management

8) Perform source data verification (SDV) activity (as sponsor requirement)

9) Review the safety Lab data (as per Data Transfer Agreement)

Job location_ : Vadodara (Gujarat)

_Experience_ : B. Pharma / M. Pharma, M.Sc . , with 2-4 years of QC experience in the clinical research industry.

Skills Required

Sop, Gcp, regulatory guidelines , Quality Control