Clinical Study Specialist

VerGo Pharma Research; Panaji; On-site; INR 600,000 - 1,200,000; Full time

Benefits offered by this job

Medical Insurance

Annual Leave with Six Days Week off

Job summary

VerGo Pharma Research in India seeks a Clinical Study Scientist/Associates for Late- Phase Trials to monitor Phase II–IV studies at investigator sites, both on-site and remotely. You will ensure data quality, protocol adherence, and patient safety while coordinating with PV/Medical teams and maintaining trial documents.

The role requires 2–5 years CRA experience, strong ICH-GCP/NDCT knowledge, and travel readiness to ensure sites stay audit-ready and enrolment progresses smoothly.

Qualifications

• 2–5 years of CRA experience in Phase II–IV trials (oncology, immunology, chronic diseases preferred).
• Strong understanding of ICH-GCP and national NDCT rules.
• Experience with EDC systems and remote monitoring tools.
• Willingness to travel frequently.

Responsibilities

• Conduct site qualification, initiation, routine monitoring, and close-out visits.
• Verify 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, 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 elevate operational risks to the CSM.
• Ensure sites remain audit-ready.
• Build relationships with investigators and coordinators to support enrolment.
• Maintain Trial Master Files and investigator communications on site.

Skills

Attention to detail

Site relationship management

Communication clarity

Problem-solving

GCP discipline

Education

Bachelor's degree in Life Sciences/Pharmacy/Nursing or related field

Tools

EDC systems

Remote monitoring tools

Job description

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 elevate operational risks to the CSM.
• Ensure sites always remain audit-ready.
• Build strong 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.