Conduct site initiation, routine monitoring, and close-out visits per protocol, SOPs, and monitoring plan
- Perform source data verification (SDV) and source document review, and resolve data querieswithin agreed timelines
- Monitor and report serious adverse events (SAEs), serious unexpected suspected adverse reactions(SUSARs), and protocol deviations
- Support CDSCO/Ethics Committee submission documentation, site regulatory files, and amendment tracking
- Liaise with investigators and site staff on subject enrolment, retention, and protocol compliance
- Maintain Investigator Site File (ISF) and Trial Master File (TMF) documentation to inspection-ready standard
- Verify investigational product accountability, storage conditions, and dispensing logs at assigned sites.
- Support site-level query resolution and Case Report Form (CRF) completion oversight
- Escalate site-level risks, enrolment shortfalls, or compliance concerns to the Clinical Operations Team Lead promptly.
Pay: ₹50,000.00 - ₹600,000.00 per month
Work Location: In person
