Job summary

Somerset NHS Foundation Trust is seeking an experienced and motivated Quality Assurance Manager (Research) to lead and shape our research quality and governance function.

This is an excellent opportunity for a QA professional who wants to work at system level, influence practice across multiple clinical specialties, and play a central role in strengthening a growing and ambitious research portfolio.

The QA Manager will be responsible for leading the Trust's research quality assurance and governance functions across both Trust-sponsored and hosted clinical trials.

The postholder will develop, implement, and maintain systems to ensure all research conducted within the Trust is compliant with UK Clinical Trials Regulations, ICH-GCP, Health Research Authority (HRA) requirements, MHRA inspection standards, and Trust policies. They will act as the operational lead for audit, monitoring, inspection readiness, and quality management, supporting the Research Manager who retains strategic oversight of research governance and sponsorship responsibilities.

This is a key senior role within the Department of Clinical Research (DoCR), with responsibility for ensuring that all research activity across the Trust, both sponsored and hosted, is delivered to the highest standards of quality, compliance, and patient safety. contributing to embedding a culture of quality across the Trust, through training, support, and partnership working with investigators, research delivery teams, and external stakeholders.

Main duties of the job

The postholder will act as the operational lead for research quality assurance, including audit, monitoring, inspection readiness and quality management systems, working closely with the Research Manager who holds operational oversight of research governance and sponsorship.

As Quality Assurance Manager, you will:

• Lead the development, implementation, and maintenance of the Trust's Research Quality Management System (QMS), including SOPs, CAPA management, and quality oversight processes
• Design and deliver a proactive internal audit and monitoring programme across all sponsored and hosted studies
• Act as the Trust's lead contact for MHRA, HRA, NIHR, and funder inspections, coordinating inspection preparation, responses, and follow up actions
• Support fulfilment of sponsor responsibilities for Trust sponsored trials, including risk assessments, monitoring strategy, safety reporting, and TMF quality checks
• Oversee governance and quality assurance for hosted studies, ensuring capacity and capability assessments, regulatory compliance, and high quality delivery
• Lead and deliver training on GCP, SOPs, and governance for investigators, research nurses, and wider Trust staff
• Supervise QA Monitors/Officers and contribute to developing QA capacity within the department

Working with the Research Manager and Head of Research to develop strategic improvements, strengthen systems, and embed a culture of research quality across the Trust.

About us

At Somerset NHS Foundation Trust, we're committed to supporting our employees with a range of benefits designed to enhance your professional and personal life. We offer:

• Flexible working options to help you balance work and life
• NHS pension scheme for long-term financial security
• Generous annual leave allowance to recharge and relax
• A strong focus on career development to help you grow and achieve your potential

Additionally, you'll gain access to our Blue Light Card, unlocking exclusive discounts on shopping, dining, and leisure activities, as well as NHS-specific perks to support you both inside and outside of work.

We are proud to foster a diverse, skilled, and inclusive workforce, and we encourage applications from all backgrounds.

Why Somerset? Somerset offers the perfect blend of idyllic countryside, outstanding areas of natural beauty, and breathtaking coastlines, with vibrant cities like Bristol, Bath, and Exeter just a short drive away - and only two hours to London.

The region is home to excellent educational facilities, and with affordable housing compared to other parts of the country, it's a great place to build both your career and your future.

Somerset truly has it all - the peaceful countryside and cosmopolitan city life, with something for everyone to enjoy.

Job description

Job responsibilities

Why join Somerset NHS FT?

• Work within a supportive, expanding research department at a Trust committed to innovation and high quality research
• Play a central role in shaping QA systems and governance for a growing research portfolio
• Opportunities for ongoing development and specialist training in research quality and governance
• Be part of a collaborative, motivated team advancing research that directly benefits patients across Somerset

For an informal discussion about the role, please contact: Flo Cullen, flo.cullen@somersetft.nhs.uk 01823 342582

Please refer to the job description for further details on the role. When completing your application please make sure to tell us how your experience and skills fit the person specification.

Job description
Job responsibilities

Why join Somerset NHS FT?

• Work within a supportive, expanding research department at a Trust committed to innovation and high quality research
• Play a central role in shaping QA systems and governance for a growing research portfolio
• Opportunities for ongoing development and specialist training in research quality and governance
• Be part of a collaborative, motivated team advancing research that directly benefits patients across Somerset

For an informal discussion about the role, please contact: Flo Cullen, flo.cullen@somersetft.nhs.uk 01823 342582

Please refer to the job description for further details on the role. When completing your application please make sure to tell us how your experience and skills fit the person specification.

Person Specification

Qualifications

Essential

• Degree in life sciences, health sciences, or related field
• Good Clinical Practice (GCP) training (current/valid)

Desirable

• Postgraduate qualification in research management, QA, or related discipline

Experience

Essential

• Substantial experience in research governance or QA within NHS, academic, or industry settings
• Experience conducting audits and managing CAPA
• Experience preparing for and supporting MHRA/HRA inspections
• Experience supporting sponsor responsibilities (e.g. monitoring, safety reporting, TMF quality checks)
• Experience advising investigators and staff on governance/QA requirements
• Experience supervising or mentoring staff

Desirable

• Experience contributing to infrastructure or capacity-building bids
• Experience with hosted and sponsored trial portfolios

Additional Criteria

Essential

• Substantial experience in research governance or quality assurance within NHS, academic, or industry settings.
• Strong knowledge of UK Clinical Trials Regulations, ICHGCP, audit processes, and CAPA management.
• Experience supporting or preparing for MHRA/HRA inspections.
• Experience advising investigators and research teams on compliance and quality requirements.
• Strong organisational, analytical, and project management skills, with the ability to manage competing priorities.
• Excellent communication skills and the confidence to influence, advise, and build relationships at all levels.

Desirable

• Experience contributing to sponsorship activities, trial monitoring, or regulatory submissions.
• Familiarity with NIHR systems and national research frameworks.
• Knowledge of ISO or broader QA frameworks.
• Experience supervising or mentoring staff.

Person Specification
Qualifications

Essential

• Degree in life sciences, health sciences, or related field
• Good Clinical Practice (GCP) training (current/valid)

Desirable

• Postgraduate qualification in research management, QA, or related discipline

Experience

Essential

• Substantial experience in research governance or QA within NHS, academic, or industry settings
• Experience conducting audits and managing CAPA
• Experience preparing for and supporting MHRA/HRA inspections
• Experience supporting sponsor responsibilities (e.g. monitoring, safety reporting, TMF quality checks)
• Experience advising investigators and staff on governance/QA requirements
• Experience supervising or mentoring staff

Desirable

• Experience contributing to infrastructure or capacity-building bids
• Experience with hosted and sponsored trial portfolios

Additional Criteria

Essential

• Substantial experience in research governance or quality assurance within NHS, academic, or industry settings.
• Strong knowledge of UK Clinical Trials Regulations, ICHGCP, audit processes, and CAPA management.
• Experience supporting or preparing for MHRA/HRA inspections.
• Experience advising investigators and research teams on compliance and quality requirements.
• Strong organisational, analytical, and project management skills, with the ability to manage competing priorities.
• Excellent communication skills and the confidence to influence, advise, and build relationships at all levels.

Desirable

• Experience contributing to sponsorship activities, trial monitoring, or regulatory submissions.
• Familiarity with NIHR systems and national research frameworks.
• Knowledge of ISO or broader QA frameworks.
• Experience supervising or mentoring staff.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Employer details

Employer name

Somerset NHS Foundation Trust
Address

Musgrove Park Hospital

Musgrove Road

Taunton

Somerset

TA1 5DA

Employer's website