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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: Flexible freelance role with opportunities for impactful work and professional growth.
- Other info: Collaborative environment with potential for further contract discussions after successful outcomes.
- Why this job: Make a real difference in patient access to essential nutrition products in the UK.
- Qualifications: Proven CRA experience, knowledge of UK regulations, and ability to manage clinical studies.
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.
Freelance Clinical Research Associate employer: PQE Group
Contact Detail:
PQE Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance Clinical Research Associate
✨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 who does.
✨Tip Number 2
Showcase your expertise! Create a solid online presence by sharing insights or articles related to clinical research on platforms like LinkedIn. This not only highlights your knowledge but also attracts potential employers looking for someone with your skills.
✨Tip Number 3
Be proactive! Don’t just wait for job postings; reach out directly to companies you admire. Express your interest in freelance roles and how you can contribute to their projects, especially in areas like regulatory approval and clinical studies.
✨Tip Number 4
Apply through our website! We’ve got a range of exciting freelance opportunities waiting for you. By applying directly, you’ll ensure your application gets the attention it deserves and you’ll be one step closer to landing that CRA role.
We think you need these skills to ace Freelance Clinical Research Associate
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. Don’t forget to mention your familiarity with UK regulatory frameworks and any specific experiences that relate to ACBS submissions.
Showcase Your Independence: Since this is a freelance position, emphasise your ability to work independently. Share examples of how you’ve successfully managed single-centre studies or navigated contract negotiations on your own.
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 the specifics of FSMP products. Being able to discuss these topics confidently will show that you're not just familiar with the role, but that you're genuinely passionate about it.
✨Showcase Your Experience
Prepare to share 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 to handle the responsibilities of the role.
✨Ask Smart Questions
Come prepared with insightful questions about the project and the team you'll be working with. This shows your interest in the role and helps you gauge if the company culture aligns with your values and work style.
✨Be Ready to Discuss Challenges
Think about potential operational risks you might encounter in this role and how you would mitigate them. Discussing these strategies during the interview can highlight your problem-solving skills and proactive approach.