Freelance Clinical Research Associate (CRA)
Posted 5 days ago by PQE Group
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: This role seeks a Freelance Clinical Research Associate (CRA) to support a regulatory and clinical program aimed at obtaining ACBS listing for FSMP thickening products in the UK. The position involves managing clinical studies, ensuring compliance with regulatory requirements, and facilitating interactions with UK Ethics Committees. The CRA will play a crucial role in documentation preparation, site monitoring, and stakeholder engagement. This opportunity is ideal for those with experience in clinical research within the pharmaceutical and clinical nutrition sectors.
Key Responsibilities:
- Support the preparation and execution of the ACBS pre-consultation package.
- Contribute to the collection, organisation, and review of documentation for ACBS submission.
- Facilitate interactions with UK Ethics Committees and support site-level regulatory readiness.
- Manage and monitor two UK-based, single-centre Clinical Acceptability Studies.
- 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.
- 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.
Key Skills:
- 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.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.