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 in office 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 Workplace, Medical Insurance, Annual Leave with Six Days Week off in a month.
📌 Clinical Study Specialist South Goa
🏢 VerGo Pharma Research
📍 South Goa
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