Clinical Research Associate

Job description

Job title: Clinical Research Associate Department: Research & Development: Location: Southampton, UK: GLS: T02: Working hours: 37.5 hours per week Mon-Fri A brighter future awaits you: What to expect: Responsible for coordination, administration and regulatory compliance of clinical trial documentation and investigational product traceability for the conduct of clinical trials during product research and development of ophthalmic medical device (Contact Lens). Also works with clinical partners, investigative sites and CROs. Essential Functions & Accountabilities: - Ensure coordination between the UK and US R&D teams for clinical studies, including study management, site management, study documentation and study product management. - Ensures compliance with Good Clinical Practices (GCP), SOPs, and applicable regulations with particular emphasis on document control, device accountability, and site monitoring. - Establishes and maintains study binder to ensure complete and accurate records of all clinical study documentation. - Organizes, distributes, tracks, files and archives all clinical study documentation including protocols, CRFs, clinical reports, product traceability, adverse...