Research Associate in Hampshire

LennTech are supporting a global medical device client who have a need for a Clinical Research Associate to join an exciting growing team. This is a permanent hybrid position of at least three days on site.

Responsibilities include:

• 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 devices (Contact Lens).
• 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.
• Establish and maintain study binder to ensure complete and accurate records of all clinical study documentation.
• Organise, distribute, track, file and archive 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.
• Coordinate and manage 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.
• Manage Clinical Inventory, including sourcing/ordering, shipping, receiving, transfer, traceability and destruction of investigational and commercial products (medical devices) used in clinical studies.
• Coordinate Sponsor in-house clinical studies (scheduling and enrolling subjects, preparing the CRFs, subject compensation and data entry).
• Coordinate, schedule and perform 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.
• Coordinate and document all study related activities including informed consent development, IRB/EC approval, study start-up, enrolment, data management and closeout.
• Coordinate clinical trial associate (CTA) personnel activity, as required.
• Perform required clinical study or administrative tasks as assigned by the clinical trial manager.

Qualifications:

• Strong cross‑functional collaboration skills, with experience working closely with clinical operations, data management, regulatory, quality, and other stakeholders.
• Working knowledge of computer operating systems (e.g. Strong Excel and database management skills, including data tracking, reconciliation, and reporting).
• Medical and technical aptitude; experience or knowledge in ophthalmic medical devices is desirable.
• Minimum 2 years’ experience in clinical research operations, previous experience as a Clinical Research Associate (CRA) preferred.
• Bachelor’s degree, biological sciences or medical/scientific-related field (or equivalent experience) required.
• BS or MA in Clinical Trial Management (or equivalent) preferred.