CooperCompanies
Senior Clinical Research Associate
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Job title: Senior Clinical Research Associate
Department: Research & Development
Location: Southampton, UK
GLS: T03
Working hours: 37.5 hours per week Monday to Friday (3 days in the office, 3 working from home)
A brighter future awaits you
Job Summary
You’ll be responsible for the operational leadership and delivery of assigned ophthalmic medical device clinical studies throughout the study lifecycle, from concept and study design through start-up, execution, close-out and reporting.
Working in close partnership with Clinical Scientists and cross-functional stakeholders, the Senior Clinical Research Associate acts as the operational study lead for assigned studies, providing expertise in study planning, site selection, budget development, vendor oversight, risk management, clinical monitoring strategy, and investigator engagement to ensure successful study delivery in compliance with GCP, SOPs and applicable regulations.
Essential Functions & Accountabilities
- Lead the planning and delivery of clinical studies, including timelines, budgets, enrolment plans, milestones and operational deliverables.
- Provide operational input into study design, protocols, feasibility assessments and execution strategies.
- Identify, assess and activate high-performing investigative sites.
- Build strong partnerships with investigators, study coordinators, Clinical Scientists and teams across Regulatory, Quality, Legal, Procurement and Finance.
- Oversee CROs, laboratories and other external vendors, ensuring delivery against agreed quality, budget, timeline and contractual expectations.
- Develop and implement risk-based monitoring plans and conduct site qualification, initiation, monitoring and close-out visits.
- Monitor site performance, enrolment and study risks, taking timely action to resolve issues and protect participant safety and data quality.
- Maintain complete, accurate and inspection-ready Trial Master Files and essential study documentation.
- Support ethics and regulatory submissions, clinical trial registrations, audits and inspections.
- Ensure studies are delivered in line with Good Clinical Practice, ISO 14155, company procedures and applicable regulatory requirements.
- Contribute to the continuous improvement of clinical processes, templates and ways of working.
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Knowledge, Skills and Abilities, Experience
- At least five years’ experience in clinical research, clinical operations or clinical trial management.
- At least three years’ experience as a Clinical Research Associate, Senior Clinical Research Associate, Clinical Trial Manager, Clinical Study Manager or equivalent.
- Proven experience leading clinical studies from start-up through to close-out, with responsibility for planning, execution and delivery.
- Ability to independently manage multiple studies, investigative sites and competing priorities.
- Experience developing study plans, timelines, budgets, enrolment strategies and risk-management plans.
- Hands-on experience conducting site qualification, initiation, monitoring and close-out visits.
- Strong experience in site feasibility, selection, activation, oversight and performance management.
- Experience working with investigators, study coordinators, CROs, vendors and cross-functional stakeholders.
- Proven experience selecting and overseeing vendors, including reviewing proposals, scopes of work, budgets and performance.
- Strong knowledge of risk-based monitoring principles and experience developing and refining monitoring plans.
- Experience managing Trial Master Files and maintaining audit and inspection readiness throughout the study lifecycle.
- Strong working knowledge of Good Clinical Practice, ISO 14155, ICH guidelines, company procedures and applicable regulatory requirements.
- Experience supporting ethics and regulatory submissions, clinical trial registrations, contracts and investigator payments.
- Excellent communication, training, organisation and stakeholder-management skills, with the ability to influence without direct authority.
- Proficiency in Microsoft Office, clinical trial management systems and Electronic Data Capture systems; experience with Veeva Vault, medical devices or ophthalmic clinical research is highly desirable.
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What we offer:
You’ll receive competitive compensation and a fantastic benefits package including, bonus, private medical, health cash plan, 25 days holiday, pension scheme, life assurance, access to our Wellness Platform to support you in mental health and wellbeing, a discounted contact lens scheme and much more!
We are committed to our employees’ personal and professional development and offer extensive training to support your career growth and help every individual to reach their full potential. To help us achieve our goals, we’ll give you everything you need to help you achieve yours.
We also provide access to LinkedIn Learning to help you develop your career and grow with CooperVision.
What you can expect:
As a CooperVision employee, you’ll be welcomed into a diverse and progressive global business. We appreciate how important fostering a diverse and inclusive culture is and how different perspectives add value and contribute to our success. With our CooperPride, African Descent, Woman’s Impact Network and Mind Body and Wellbeing Employee Resource Groups, we offer opportunities for employees to learn and grow within an inclusive and safe space.
If you like what you see, take the first step towards your Brighter Future and apply today! All suitably qualified applicants will receive equal consideration and opportunities from CooperVision.
Please view our careers page at https://hcjy.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/CX_1 to view all other opportunities.
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