Clinical Research Associate (oncology/ medical devices/ regulatory)

Role & responsibilities

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 queries

within 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

Preferred candidate profile

B.Pharm / M.Pharm / Life Sciences graduate; nursing or paramedical background also considered

• 3-5 years of CRA experience in a CRO or pharmaceutical company, with at least 1 year

specifically in oncology, haematology, or immunology trials

• Demonstrated experience independently managing a portfolio of 4-5 concurrent clinical trial sites
• Working knowledge of ICH-GCP, Indian New Drugs and Clinical Trial Rules 2019, and Schedule

Y requirements