Clinical Research Associate (CRA)

Roles & Responsibilities
Clinical Trial Start-Up
• Assist in preparation of study protocols, Investigator’s Brochure, CRFs, and patient information documents
• Coordinate with Ethics Committees and Regulatory Authorities for approvals
• Conduct site feasibility assessments and support investigator selection
• Assist in site initiation and training activities
Trial Monitoring & Execution
• Perform routine on-site monitoring visits
• Conduct Source Data Verification (SDV)
• Ensure CRF accuracy and regulatory compliance as per ICH-GCP guidelines
• Train site staff on study-specific procedures
• Manage Investigational Medicinal Product (IMP) accountability
• Ensure protocol adherence and subject safety
Documentation & Close-Out
• Prepare monitoring visit reports and follow-up letters
• Maintain Trial Master File (TMF) and essential documents
• Support audit and inspection readiness
• Close trial sites and archive documentation upon study completion
• Prepare final reports for sponsors and regulatory authorities

Qualification
• Degree in Life Sciences / Medical Sciences / Nursing from a recognized institution
• Bachelor of Pharmacy
• Master of Pharmacy
• Doctor of Pharmacy

Experience
• Minimum 2 years of clinical trial coordination or monitoring experience
• Experience in NCD, cardiovascular, or renal trials preferred
• Experience in regulatory submissions and ethics committee processes

Skills
• Strong knowledge of ICH-GCP guidelines
• Understanding of regulatory approvals and ethics submissions
• Clinical documentation and CRF handling expertise
• Site monitoring and stakeholder coordination skills
• Willingness to travel for monitoring visits
• Excellent English communication and report-writing skills

About the Organization
The George Institute for Global Health is a globally recognized medical research organization operating in over 40 countries, focused on improving health outcomes worldwide through high-impact research in non-communicable diseases, including cardiovascular, renal, and chronic conditions.