Clinical Research Associate (oncology/ medical devices/ regulatory)

Auriga Research; Gurugram District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Auriga Research in India is seeking a Clinical Research Associate to conduct site initiation, routine monitoring and close-out visits per protocol, SOPs, and monitoring plans. You will perform SDV, source document review, and resolve data queries within agreed timelines.

Role requires monitoring SAEs/SUSARs, supporting regulatory submissions, and maintaining TMF/ISF. Manage enrollment across 4–5 sites with strong ICH-GCP knowledge and oncology trial experience.

Qualifications

• 3–5 years of CRA experience in a CRO or pharmaceutical company.
• Experience in oncology, haematology, or immunology trials.
• Independent management of a portfolio of 4–5 concurrent sites.
• Working knowledge of ICH-GCP, Indian New Drugs and Clinical Trial Rules 2019.

Responsibilities

• Perform site initiation, routine monitoring and close-out visits per protocol and SOPs.
• Conduct SDV and source document review; resolve data queries within deadlines.
• Monitor and report SAEs, SUSARs, and protocol deviations to timelines.
• Support regulatory submissions and amendment tracking; maintain ISF/TMF.
• Ensure site-level query resolution and CRF completion; escalate risks promptly.

Skills

CRA experience

Regulatory knowledge

Site monitoring

Education

B.Pharm / M.Pharm / Life Sciences

Tools

TMF management

Job description

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