We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our client's team in the field of Ophthalmic Medical Devices. The CRA will play a crucial role in facilitating and managing clinical trials for their innovative ophthalmic medical devices. Working closely with private practitioners across the UK, the CRA will ensure compliance with regulatory requirements, monitor trial progress, and support the successful execution of clinical studies.

Responsibilities:

• Assist in the planning, implementation, and execution of clinical trials for ophthalmic medical devices across the UK.
• Collaborate with cross-functional teams to establish study protocols, timelines, and milestones.
• Identify and evaluate potential private practitioner sites for participation in clinical trials.
• Establish and maintain strong relationships with private practitioners and clinical site staff to ensure seamless study conduct.
• Conduct site initiation visits and provide necessary training to site personnel.
• Ensure adherence to all relevant regulatory guidelines, Good Clinical Practice (GCP), and company standard operating procedures (SOPs) throughout the clinical trial process.
• Assist in the preparation and submission of necessary regulatory documents to obtain approvals and clearances.
• Conduct on-site monitoring visits to assess study progress, data accuracy, and site compliance with the study protocol.
• Collect and review clinical trial data, including source documents, case report forms (CRFs), and electronic data capture systems.
• Monitor patient safety and report adverse events in compliance with regulatory requirements and internal safety reporting procedures.
• Ensure data quality and integrity by conducting routine data review and query resolution.
• Maintain accurate and up-to-date study documentation, including investigator files, trial master files, and essential documents.
• Prepare and assist with the compilation of study reports, presentations, and documentation for regulatory submissions.
• Collaborate with the clinical team, investigators, and study coordinators to address any study-related issues or queries promptly.
• Participate in meetings and conference calls to update key stakeholders on study progress and discuss strategies for improvement.

Requirements:

• Bachelor's degree in a life sciences or healthcare-related field (e.g., biology, pharmacy, nursing, etc.). A Master's degree is a plus.
• Proven experience as a Clinical Research Associate, preferably in ophthalmology or medical device trials.
• In-depth knowledge of clinical trial regulations, GCP, and other relevant guidelines.
• Strong organizational, communication, and interpersonal skills to effectively interact with diverse stakeholders.
• Detail-oriented, with the ability to manage multiple tasks simultaneously and meet tight deadlines.
• Proficiency in using clinical trial databases and electronic data capture (EDC) systems.
• Willingness to travel frequently for on-site monitoring visits across the UK.