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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 to make a real impact.
- Other info: Collaborative environment with opportunities for professional growth.
- Why this job: Contribute to meaningful projects that enhance patient access to vital nutrition products.
- Qualifications: Experience as a CRA in the UK with knowledge of regulatory frameworks.
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.
Responsibilities include, but are not limited to, the following:
- Support the preparation and execution of the ACBS pre-consultation package, ensuring alignment between clinical strategy and ACBS expectations
- 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
- Act as the primary point of contact for the investigational site (specialised in dysphagia)
- 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
About you:
- 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
- Experience with ACBS processes and submissions is preferred
- Experience interacting with UK Ethics Committees
- Demonstrated experience managing single-centre clinical studies
- Solid understanding of ICH-GCP (E6) guidelines
- Strong organisational and communication skills
- Ability to work independently in a freelance/contract capacity
- Willingness to travel within the UK as required
Next Steps
Upon receiving your application, if a match is identified, you will be contacted for an initial discussion. Following a positive outcome, further discussions with the project team will be arranged. If successful, we will proceed with contract discussions. Alternatively, you will be informed if your application is not progressed.
Working with Us
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 (CRA) employer: PQE Group
Contact Detail:
PQE Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Freelance Clinical Research Associate (CRA)
✨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 hearing about freelance opportunities before they even hit the job boards.
✨Tip Number 2
Showcase your expertise! Create a standout LinkedIn profile that highlights your experience as a Clinical Research Associate. Share articles, insights, or even your own content related to clinical nutrition and regulatory processes to position yourself as a thought leader in the field.
✨Tip Number 3
Be proactive! Don’t just wait for job postings to come to you. Reach out directly to companies you’re interested in working with, like us at StudySmarter. Express your interest in freelance roles and share how your skills can contribute to their projects.
✨Tip Number 4
Prepare for interviews by brushing up on your knowledge of ACBS processes and UK regulatory frameworks. Be ready to discuss your previous experiences managing clinical studies and how you can bring value to the team. Confidence is key!
We think you need these skills to ace Freelance Clinical Research Associate (CRA)
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, and showcase your knowledge of UK regulatory frameworks.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for this role. Mention specific experiences that align with the responsibilities listed in the job description, like managing clinical studies or interacting with Ethics Committees.
Showcase Your Skills: Don’t forget to highlight your strong organisational and communication skills. We want to see how you’ve used these skills in past roles, especially in managing single-centre clinical studies and ensuring protocol compliance.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. This way, we can easily track your application and get back to you quickly if there's a match!
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 ACBS processes. Familiarise yourself with the specific requirements for FSMP thickening products, as this will show that you're not just a generalist but someone who understands the nuances of the role.
✨Showcase Your Experience
Prepare to discuss your previous experiences managing single-centre clinical studies. Be ready to share specific examples of how you've ensured protocol compliance and data integrity, as well as any challenges you faced and how you overcame them.
✨Engage with the Team
During the interview, demonstrate your ability to collaborate with cross-functional teams. Talk about how you've facilitated interactions with Ethics Committees or managed stakeholder relationships in past roles. This will highlight your communication skills and teamwork.
✨Ask Insightful Questions
Prepare some thoughtful questions about the project and the team dynamics. Inquire about their approach to risk management or how they ensure audit readiness. This shows your genuine interest in the role and helps you assess if it's the right fit for you.