Job Description
Job title: Clinical Research Associate
Department: Research & Development
Location: Southampton, UK
GLS: T02
Working hours: 37.5 hours per week Mon‑Fri
Responsibilities
* Ensure coordination between UK and US R&D teams for clinical studies, including study management, site management, study documentation and study product management.
* Ensure compliance with Good Clinical Practices (GCP), SOPs and applicable regulations, focusing on document control, device accountability and site monitoring.
* Establish and maintain study binders to ensure complete and accurate records of all clinical study documentation.
* Organize, distribute, track, file and archive all clinical study documentation including protocols, CRFs, clinical reports, product traceability, adverse event tracking and communications with IRB/ECs 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 site training and maintain agreements, site visit and training logs.
* Ensure robust interactions between Sponsor and study site personnel to prevent, address and resolve issues.
* Manage Clinical Inventory, including sourcing/ordering, shipping, receiving, transfer, traceability and destruction of investigational and commercial products (medical devices) used in clinical studies.
* Liaise with CROs during study initiation.
* Coordinate Sponsor in‑house clinical studies (scheduling and enrolling subjects, preparing CRFs, subject compensation and data entry).
* Coordinate, schedule and perform a program of clinical study monitoring, via remote or on‑site document and data review, to ensure 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, enrollment, data management and closeout.
* Develop SOPs and work‑instruction as applicable.
* Coordinate CTA personnel activity as required.
* Perform required clinical study or administrative tasks as assigned by the clinical trial manager.
Qualifications
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.
* 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. CTMS/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 desirable.
* Professional demeanor with a high level of integrity and accountability.
Education
* Bachelor’s degree in biological sciences or medical/scientific‑related field (or equivalent experience) required.
* BS or MA in Clinical Trial Management (or equivalent) preferred.
* ACRP Certification (or equivalent) highly desirable.
Benefits
Competitive compensation and a benefits package including 25 days holiday, pension scheme, healthcare cover, life assurance and access to a Wellness Platform. Additional benefits include a discounted contact lens scheme and further employee development opportunities.
All suitably qualified applicants will receive equal consideration and opportunities.
#J-18808-Ljbffr