Clinical Research Associate (CRA)

Roles & Responsibilities
• Assist in preparation of protocol, Investigator’s Brochure, CRF, and patient information documents
• Coordinate with Ethics Committees and Regulatory Authorities for submissions and approvals
• Conduct site feasibility assessments and support investigator selection and site initiation
• Perform on-site monitoring visits and Source Data Verification (SDV)
• Ensure CRF accuracy, regulatory compliance, and adherence to ICH-GCP guidelines
• Train site staff on study-specific procedures and protocol requirements
• Manage Investigational Medicinal Product (IMP) accountability
• Prepare monitoring visit reports and maintain trial documentation
• Archive study documents and prepare final reports for sponsors and authorities
• Support site close-out activities upon study completion

Qualification
• B.Pharm / M.Pharm / Pharm.D / Life Sciences / Medical Sciences / Nursing

Experience
• Minimum 2 years of clinical trial coordination or clinical research experience
• Experience in site monitoring, ethics submissions, and regulatory coordination
• Knowledge of ICH-GCP and clinical documentation practices

Skills
• Strong understanding of ICH-GCP guidelines and regulatory processes
• Experience in CRF handling and clinical documentation management
• Ability to coordinate with multi-site stakeholders
• Willingness to travel for site monitoring visits
• Excellent English communication skills
• Strong organizational and time management abilities

About the Company
The George Institute for Global Health is a globally recognized medical research organization affiliated with leading universities and operating in more than 40 countries. With a strong focus on non-communicable diseases such as cardiovascular, renal, and chronic disorders, the institute conducts large-scale international clinical trials aimed at improving global health outcomes. It promotes diversity, ethical research standards, and collaborative clinical research excellence.