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 responsible adverse events (SAEs), reliable unexpected suspected adverse reactions(SUSARs), and protocol deviations
Support CDSCO/Ethics Committee submission documentation, site regulatory files, and amendment tracking
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

📌 Clinical Research Associate Oncology Gurugram (India)
🏢 Arbro Pharmaceuticals
📍 India