Clinical Research Associate

Roles & Responsibilities
• Ensure clinical trials are conducted in compliance with ICH-GCP, approved protocols, and regulatory requirements
• Prepare, review, and maintain essential clinical trial documentation
• Generate, review, and resolve data entry queries in eCRF systems
• Manage clinical research data for ongoing and new electronic clinical trials
• Conduct UAT testing and support validation of clinical trial software applications
• Analyze clinical trial data and prepare reports for sponsors and data coordinators
• Act as a liaison between Data Management and cross-functional teams
• Maintain data management documentation, trackers, and study records
• Ensure accuracy, consistency, and integrity of clinical trial data
• Prepare presentations and reports on study progress and milestones

Qualification
• UG: B.Pharm / B.E. (Biotechnology / Biochemistry)
• PG: M.Pharm (Any Specialization)

Experience
• 1–5 years of relevant experience in clinical research or clinical operations preferred

Skills
• Strong knowledge of ICH-GCP guidelines
• Experience in clinical data management
• Hands-on exposure to eCRF and electronic clinical trial systems
• Good analytical, documentation, and reporting skills
• Strong communication and coordination abilities

About the Organization
Aithent is a technology-driven clinical research organization supporting global clinical trials through innovative electronic systems, data management solutions, and regulatory-compliant clinical operations, offering professionals strong learning and career growth opportunities in the CRO industry.