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- Tasks: Support impactful clinical projects and regulatory approvals in the nutrition space.
- Company: Innovative company focused on clinical nutrition and regulatory initiatives.
- Benefits: Freelance flexibility, competitive pay, and the chance to make a real difference.
- Other info: Opportunity for career growth and engagement with key stakeholders.
- Why this job: Join a collaborative team and help bring essential products to patients in the UK.
- 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 Trials Assistant-clinical Trials Unit employer: PQE Group
Contact Detail:
PQE Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Trials Assistant-clinical Trials Unit
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical research field, attend industry events, and join relevant online forums. The more people you know, the better your chances of landing that Clinical Trials Assistant gig.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of UK regulatory frameworks and ACBS requirements. We want you to shine when discussing your experience with FSMP products and clinical studies!
✨Tip Number 3
Showcase your skills through practical examples. When chatting with potential employers, highlight specific projects where you managed clinical studies or ensured protocol compliance. This will help them see how you can contribute to their team.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Clinical Trials Assistant-clinical Trials Unit
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 trials and how your skills align with our needs. Don’t just repeat your CV; use this space to showcase your personality and enthusiasm for the role.
Showcase Your Regulatory Knowledge: Since this role involves navigating UK regulatory frameworks, make sure to highlight any specific experiences you have with ACBS submissions or interactions with Ethics Committees. We want to see that you know your stuff!
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 and ethical frameworks, especially as they relate to clinical trials. Familiarise yourself with ACBS requirements and the specifics of FSMP products. This will show that you're not just interested in the role but also understand the nuances of the industry.
✨Showcase Your Experience
Prepare to discuss your previous experience as a Clinical Research Associate. Be ready to share specific examples of how you've managed single-centre clinical studies, handled documentation for regulatory submissions, or facilitated interactions with Ethics Committees. Concrete examples will help you stand out.
✨Demonstrate Problem-Solving Skills
Think about potential operational risks that could arise during clinical trials and be prepared to discuss how you would mitigate them. This shows that you can think critically and proactively, which is essential for the role.
✨Engage with the Team
During the interview, don’t hesitate to ask questions about the project team and their collaborative approach. Showing genuine interest in how you can contribute to a focused environment will reflect positively on you. It’s all about teamwork in this role!