Research Associate - Clinical Trial (3-8 yrs)
Post : Clinical Research Associate/Clinical Trial
Location : Ahmedabad-(Science City Road, Sola)
Exp : 3Yrs to 8Yrs
Roles & Responsibilities:
- Perform on-site in-process and retrospective monitoring visit of clinical phase of the clinical trials, PK and BA/BE studies.
- Site feasibility, qualification, initiation, monitoring and close out meetings at different CROs for clinical trials, PK and BA/BE studies.
- Overseeing the progress of a clinical trial and BA-BE studies, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
- Checking documents of CRO/Site internal System audit at specified interval and related documents and CAPA.
- Monitor and track patient enrolment and study progress in case of Clinical Phase
- To review all data produced from IB, SOPs of Different CROs, Drug Accountability Form, Periodic Visit Checklist, Inform Consent Form, Case Report Form, and Source Data and resolve any data queries/protocol deviations identified with Preparation of Final Clinical Study Report.
- Prepare the Monitoring Reports and taking follow up for the corrective actions and preventive actions.
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