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 event tracking and communications with institutional review board/ethics committee and clinical investigators, ensuring timely completion of milestones.
• Coordinates and manages the flow of documents and study materials between Sponsor and clinical sites related to the conduct of clinical trials during contact lens (medical device) product development.
• Manages site training and maintain agreements, site visit & training logs.
• Ensures robust interactions between Sponsor and study site personnel to prevent, address and resolve issues
• Manages Clinical Inventory, including sourcing/ordering, shipping, receiving, transfer, traceability and destruction of investigational and commercial products (medical devices) used in clinical studies.
• Liaises and works with CROs in the initiation of required studies.
• Coordinates Sponsor in-house clinical studies (scheduling and enrolling subjects, preparing the CRFs, subject compensation and data entry).
• Coordinates, schedules and performs a program of clinical study monitoring, as appropriate, via remote or on-site document and data review to ensure study site compliance with GCP, SOPs, study protocols, and applicable regulations.
• Coordinates and documents all study related activities including, informed consent development, IRB/EC approval, study start-up, enrollment, data management and closeout.
• SOP and work-instruction development, as applicable.
• Coordinates clinical trial associate (CTA) personnel activity, as required.
• Performs required clinical study or administrative tasks as assigned by the clinical trial manager.

About you:

Experience:

• Minimum 2 years’ experience in clinical research operations, previous experience as a Clinical Research Associate (CRA) preferred.
• Experience of working with CROs, preferred.

Knowledge, Skills and Abilities:

• Excellent administrative, organizational and study oversight skills
• Strong attention to detail with a systematic, meticulous work approach to work
• Excellent verbal and written communication skills, including appropriate use of medical and scientific terminology
• Proven ability to work effectively to deadlines and manage competing priorities in a fast‑paced environment
• Strong cross‑functional collaboration skills, with experience working closely with clinical operations, data management, regulatory, quality, and other stakeholders
• Demonstrated ability to quickly assimilate, interpret, and apply new information
• Working knowledge of computer operating systems (e.g. C TMS/EDC/eTMF systems)
• Strong Excel and database management skills, including data tracking, reconciliation, and reporting
• Well-organized with ability to multitask and adjust to changing priorities
• Medical and technical aptitude; experience or knowledge in ophthalmic medical devices is desirable
• Professional demeanour with a high level of integrity and accountability

Education:

• Bachelor’s degree, biological sciences or medical/scientific-related field (or equivalent experience) required.
• BS or MA in Clinical Trial…