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- Tasks: Support regulatory approval and clinical evidence generation for innovative nutrition products.
- Company: Join a dynamic team in the pharmaceutical and clinical nutrition space.
- Benefits: Freelance flexibility, impactful projects, and collaboration with key stakeholders.
- Other info: Engage in a focused environment with opportunities for professional growth.
- Why this job: Make a real difference in patient access to essential nutrition products.
- Qualifications: Experience as a Clinical Research Associate and knowledge of UK regulations.
The predicted salary is between 30000 - 40000 £ per year.
Are you ready to contribute to an innovative and highly specialized clinical and regulatory program within the Pharmaceutical and Clinical Nutrition space? This opportunity offers the chance to work on impactful projects supporting regulatory approval pathways and clinical evidence generation in the UK market.
Due to ongoing project needs, we are looking for a Freelance Clinical Research Associate (CRA) to support a regulatory and clinical program focused on obtaining ACBS (Advisory Committee on Borderline Substances) listing for Food for Special Medical Purposes (FSMP) thickening products in the United Kingdom.
- Contribute to the collection, organisation, and review of documentation required for ACBS submission.
- Facilitate interactions with UK Ethics Committees and support site-level regulatory readiness, including contract negotiation and finalisation.
- Manage and monitor two UK-based, single-centre Clinical Acceptability Studies in accordance with ACBS Appendix 5 requirements.
- Perform site initiation visits, monitoring activities, and close-out visits.
- Ensure protocol compliance, data integrity, and timely achievement of study milestones.
- Conduct source data verification (SDV) and oversee query resolution processes.
- Support site training, engagement, and performance tracking.
- Ensure completeness of site documentation and maintain audit/inspection readiness.
- Support the implementation of a bridging strategy across studies.
- Identify operational risks and propose mitigation strategies.
- Collaborate with cross-functional teams to ensure alignment with regulatory and ACBS requirements.
Proven experience as a Clinical Research Associate (CRA) within the UK. Strong knowledge of UK regulatory and ethical frameworks. Experience in clinical studies involving FSMP or clinical nutrition products. Demonstrated experience managing single-centre clinical studies. Ability to work independently in a freelance/contract capacity. Willingness to travel within the UK as required.
Following a positive outcome, further discussions with the project team will be arranged. If successful, we will proceed with contract discussions. By joining this project, you will be part of a focused and collaborative environment working on a meaningful regulatory initiative. This role offers the opportunity to contribute to innovative clinical nutrition products, engage with key stakeholders, and play a critical role in bringing products closer to patient access in the UK.
If you are looking for a challenging and rewarding freelance opportunity, apply now and take the next step in your clinical research career.
Clinical Research Associates Wanted employer: PQE Group
Contact Detail:
PQE Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Research Associates Wanted
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field and let them know you're on the lookout for freelance opportunities. You never know who might have a lead or can introduce you to someone hiring.
✨Tip Number 2
Get your online presence sorted! Make sure your LinkedIn profile is up-to-date and showcases your experience as a Clinical Research Associate. Join relevant groups and engage with posts to increase your visibility in the industry.
✨Tip Number 3
Don’t just apply anywhere—focus on companies that align with your values and expertise. Check out our website for openings that match your skills, especially in clinical nutrition and regulatory programs. Tailor your approach to each opportunity!
✨Tip Number 4
Prepare for interviews by brushing up on your knowledge of UK regulatory frameworks and ACBS requirements. Be ready to discuss your past experiences and how they relate to the projects you'll be working on. Confidence is key!
We think you need these skills to ace Clinical Research Associates Wanted
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience as a Clinical Research Associate. Focus on relevant projects, especially those involving FSMP or clinical nutrition products, to show us you’re the right fit for this role.
Craft a Compelling Cover Letter: Your cover letter should tell us why you’re passionate about clinical research and how your skills align with our needs. Be specific about your experience with UK regulatory frameworks and any successful studies you've managed.
Showcase Your Independent Work Style: Since this is a freelance position, emphasise your ability to work independently. Share examples of how you've successfully managed projects on your own, including any challenges you overcame along the way.
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 don’t miss out on any important updates regarding your application status.
How to prepare for a job interview at PQE Group
✨Know Your Stuff
Make sure you brush up on your knowledge of UK regulatory frameworks and clinical nutrition products. Familiarise yourself with ACBS requirements and be ready to discuss how your experience aligns with the role. This will show that you're not just a good fit, but that you're genuinely interested in the position.
✨Showcase Your Experience
Prepare specific examples from your past work as a Clinical Research Associate. Highlight your experience managing single-centre studies and any interactions you've had with Ethics Committees. This will help demonstrate your capability and give the interviewers confidence in your skills.
✨Ask Smart Questions
Come prepared with insightful questions about the project and the team you'll be working with. Inquire about their approach to risk management or how they ensure protocol compliance. This shows that you're engaged and thinking critically about the role.
✨Be Ready to Discuss Challenges
Think about potential challenges you might face in this role, such as contract negotiations or site training. Be prepared to discuss how you would handle these situations, showcasing your problem-solving skills and ability to work independently in a freelance capacity.