At a Glance
- Tasks: Coordinate clinical trials and ensure compliance with regulations for innovative ophthalmic devices.
- Company: Leading company in medical device research with a focus on eye care.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Why this job: Join a dynamic team making a real difference in healthcare through cutting-edge research.
- Qualifications: Strong organisational skills and a passion for clinical research.
- Other info: Exciting career path with potential for international collaboration.
The predicted salary is between 36000 - 60000 £ per year.
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.
Clinical Research Associate in Eastleigh employer: CooperCompanies
Contact Detail:
CooperCompanies Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associate in Eastleigh
✨Tip Number 1
Network like a pro! Reach out to professionals in the clinical research field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that Clinical Research Associate role.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of Good Clinical Practices (GCP) and the specifics of ophthalmic medical devices. We recommend practising common interview questions with a friend to boost your confidence!
✨Tip Number 3
Showcase your organisational skills! During interviews, highlight your experience with document control and study management. We want to see how you can keep everything running smoothly in a fast-paced environment.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. We’re always on the lookout for passionate candidates who are ready to make an impact in clinical research.
We think you need these skills to ace Clinical Research Associate in Eastleigh
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Clinical Research Associate role. Highlight relevant experience in clinical trials, regulatory compliance, and any specific skills that match the job description. We want to see how you fit into our team!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about clinical research and how your background aligns with our needs. Keep it concise but engaging – we love a good story!
Showcase Your Attention to Detail: In this role, attention to detail is key. Make sure your application is free from typos and errors. We appreciate candidates who take the time to ensure their documents are polished and professional.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just follow the prompts!
How to prepare for a job interview at CooperCompanies
✨Know Your Clinical Research Basics
Brush up on your knowledge of Good Clinical Practices (GCP) and the regulatory landscape. Be ready to discuss how you ensure compliance in clinical trials, especially in relation to document control and device accountability.
✨Familiarise Yourself with the Role
Understand the specific responsibilities of a Clinical Research Associate, particularly in ophthalmic medical devices. Think about how your previous experiences align with coordinating between teams and managing study documentation.
✨Prepare for Scenario Questions
Expect questions that ask how you would handle specific situations, like resolving issues between sponsors and clinical sites. Use the STAR method (Situation, Task, Action, Result) to structure your answers effectively.
✨Showcase Your Communication Skills
Since this role involves liaising with various stakeholders, be prepared to demonstrate your communication skills. Share examples of how you've successfully interacted with clinical partners or managed site training in the past.