Clinical Research Associate

Roles & Responsibilities
• Coordinate and conduct clinical studies for new products in compliance with SOPs, ICH-GCP, and applicable regulatory guidelines
• Set up clinical trial sites and liaise with investigators, doctors, and consultants for smooth trial conduct
• Coordinate with Ethics Committees and ensure compliance with GCP, SOPs, and regulatory requirements
• Prepare and submit documentation to Institutional Review Boards for clinical study approvals
• Monitor clinical trials throughout the study duration, including onsite monitoring visits
• Perform source data verification and periodic data reviews for safety and compliance
• Maintain Trial Master File at study sites and manage participant compensation budgets
• Prepare Clinical Investigation Reports and Clinical Evaluation Reports as per applicable standards
• Review and support Clinical Evaluation Reports for CE-marked medical devices
• Plan and execute Post Market Surveillance activities including PMS, PMCF, and Periodic Safety Update/User Reports

Qualification
• Degree in Life Sciences, Pharmacy, Biomedical Engineering, or related clinical research discipline

Experience
• Experience in clinical research or clinical studies preferred
• Hands-on exposure to ethics committee coordination and clinical trial monitoring desirable

Skills
• Strong understanding of ICH-GCP, SOPs, and regulatory requirements
• Clinical trial monitoring and site management skills
• Source data verification and clinical documentation expertise
• Good communication and coordination skills with investigators and ethics committees
• Strong attention to detail and compliance-oriented mindset
• Ability to work independently and as part of a multidisciplinary team

About the Company
Aurolab is a leading medical device manufacturing organization based in Madurai, India, known for its contribution to affordable and high-quality ophthalmic and healthcare solutions. Associated with the Aravind Eye Care ecosystem, Aurolab focuses on innovation, clinical excellence, and regulatory compliance to improve access to essential medical technologies globally.