Job Title: Clinical Study Scientist/Associates-(Late- Phase Trials)
Department: Clinical Operations Patient Trials
Reporting: Clinical Study Manager
Role Overview:
The CRA will be responsible for on-site and remote monitoring of Phase II/III/IV clinical trials, ensuring high-quality data, protocol adherence, and patient safety across investigator sites.
Role & responsibilities
Conduct site qualification, initiation, routine monitoring, and close-out visits.
- Verify source data (SDV), ensure accurate CRF/EDC entries, and track query resolution.
- Train site staff on protocol, GCP, safety reporting, and EDC/IRT systems.
- Monitor patient recruitment, informed consent processes, and protocol compliance.
- Ensure timely reporting of SAEs and coordinate with PV/Medical teams.
- Maintain essential documents and support eTMF completeness.
- Identify site issues and escalate operational risks to the CSM.
- Ensure sites always remain audit-ready.
- Build robust relationships with investigators and coordinators to support enrolment.
- Maintain internal documentation, Trial Master files, investigator correspondence and other essential documents on site.
Preferred candidate profile
Qualifications & Experience:
- Bachelors degree in Life Sciences, Pharmacy, Nursing, or related field.
- 2–5 years of CRA experience in Phase II–IV trials (oncology, immunology, chronic diseases preferred).
- Strong understanding of ICH-GCP and NDCT rules.
- Experience with EDC systems and remote monitoring tools.
- Willingness to travel frequently.
Competencies:
- Attention to detail
- Site relationship management
- Communication clarity
- Problem-solving
- GCP discipline
Perks and Benefits
We offer Best Deserving CTC, Good Work Environment, Medical Insurance, Annual Leave with Six Days Week off in a month.
📌 Clinical Study Specialist (South Goa)
🏢 VerGo Pharma Research
📍 South Goa
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.