Job Title

Role Objective: The Clinical Research Associate (CRA) is responsible for overseeing and coordinating clinical trials, ensuring compliance with regulatory requirements, and managing site activities. The role involves monitoring study sites, collecting and verifying data, and ensuring adherence to clinical trial protocols and Good Clinical Practice (GCP) guidelines. Desired Candidate Profile: A bachelor’s degree in optometry with a strong background in clinical research. Minimum of 3 to 6 years of experience in site management and clinical trial coordination. Knowledge of regulatory requirements, ethical guidelines, and clinical trial processes. Experience in coordinating with ethics committees and submitting regulatory dossiers. Strong analytical and problem-solving skills, particularly in managing data discrepancies. Ability to liaise with investigators and conduct feasibility assessments. Excellent communication and team collaboration skills. Proactive approach with a commitment to process improvement. Role and Responsibilities: Identify and assess potential investigators for clinical trials. Coordinate and manage regulatory and ethics committee submissions for multiple study sites. Review and ensure accuracy of clinical study documents. Oversee clinical trial execution from initiation to close-out. Register clinical trials on various regulatory platforms as per local regulations. Ensure timely data collection from sites for ongoing projects. Support investigators in manuscript preparation and submission. Track overall project progress and escalate issues to the project manager as needed. Set up trial sites, ensuring the availability of investigational medicinal products (IMP) and other trial materials. Perform source data/document verification (SDV) and ensure data consistency. Collect and manage completed case report forms (CRFs) from study sites. Train site staff on protocol requirements, proper documentation, and reporting procedures. Manage investigational product (IP) and trial materials, ensuring compliance with SOPs and GCP guidelines. Conduct site visits, including initiation, routine monitoring, and close-out visits. Handle source data verification, query management, and protocol amendments. Submit notifications for protocol amendments and additional sites to regulatory agencies. Address and resolve any trial-related issues. Functional Skills Required: Strong understanding of clinical research methodologies and trial management. Experience in site feasibility assessment and investigator management. Proficiency in regulatory and ethics committee submissions. Familiarity with clinical data management, EDC systems, and e-CRFs. Ability to manage investigational products and trial materials. Behavioral Skills Required: Strong communication and interpersonal skills. Ability to work collaboratively with cross-functional teams. Detail-oriented with strong organizational skills. Ability to work proactively and independently. Problem-solving mindset with analytical capabilities. Team Size to be Handled: Individual contributor role, reporting to Manager - Clinical Operation. Important Links: Website: LinkedIn: Instagram: Biotech Vision Care Biotech is an Equal Opportunity Organisation promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.