University Hospital Southampton NHS FT
R&D Quality Assurance Officer
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Job Overview
University Hospital Southampton NHS Foundation Trust is delighted to offer a fantastic opportunity to work with us.
Please see below for the detailed job description of the role.
Main duties of the job
The Research and Development Department at University Hospital Southampton NHS Foundation Trust are looking for an R&D Quality Assurance Officer who will help take responsibility for the safe delivery of research studies by the Trust. A key responsibility of the role is to ensure all QA activities are carried out and documented so that the Trust is inspection-ready at all times. The role is varied, as it involves working with a range of teams and colleagues to provide a safe, quality-focused framework for research at the Trust.
About The Team
University Hospital Southampton NHS Foundation Trust and University of Southampton partnership is recognised as a centre of excellence in clinical research, securing research funding in excess of £30m per annum. With state-of-the-art clinical research facilities opened in 2010, the Trust, in partnership with the University, is making excellent progress in achieving its aim of being one of the top research-active Trusts in the country.
Working for our organisation
University Hospital Southampton is one of England's largest acute teaching Trusts, offering a wide range of learning and development opportunities to support your career aspirations.
Located on the south coast with an international airport and direct rail links to London, Southampton offers an ideal setting to live and work, with the New Forest, South Downs and Jurassic Coast.
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At UHS, we’re committed to providing a flexible working environment where possible. Whether you are balancing family, study, or your wellbeing with your career, we want to support you so you can help our patients.
At UHS, we proudly champion individuality, recognising that outstanding care is only possible with a diverse, inclusive team. We’re committed to creating an anti-racist, anti-discriminatory environment where everyone feels valued, safe, and empowered to make a meaningful impact in our communities. We welcome applicants of all backgrounds, identities, and experiences to join us in building a healthcare community where everyone can belong, thrive, and contribute.
Detailed Job Description And Main Responsibilities
You can read an overview of the role's main duties in the section below: Job Description and Main Responsibilities.
To understand the role in more detail, please read the full job description and person specification documents attached.
What You’ll Do
As an R&D QA Officer, you will work closely with several teams and individuals in R&D and the wider Trust to ensure the delivery of the UHS R&D strategy meets regulatory and governance needs. This will include:
- Supporting the Deputy R&D Governance, QA and Sponsorship Manager and Senior QA Leads in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Trust.
- Supporting the Trust's preparation for external audit and regulatory inspection.
- Assisting in the delivery of QA initiatives to ensure that the Trust meets required standards for the conduct of clinical research.
- Assisting with the development and use of systems for recording and collating information for audits, using analytical skills to interpret metrics information required for audit reporting methods.
- Supporting the general administration of the QA team.
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What We’re Looking For
This post requires a dynamic, outgoing person since a key aim in the role will be to develop relationships with researchers and other staff to ensure cooperation with the quality agenda. Good IT skills are essential, and the successful applicant should be able to provide evidence of continuing professional development.
The following skills and experience are required for this post:
- An understanding of the governance requirements surrounding clinical research in the NHS
- An understanding of R&D issues in the NHS
- Excellent interpersonal and communication skills.
- Excellent IT skills, particularly in the use of web applications
- A flexible approach to work and the ability to adjust workload to changing priorities
Person specification
Qualifications, Knowledge And Experience
Essential criteria
- Educated to degree level or able to demonstrate equivalent knowledge and experience of administrative skills and understanding relevant to the role.
- Evidence of continuous professional development.
- Evidence of recent certified training in ICH GCP.
- Proven experience of developing and implementing quality assurance procedures.
- Knowledge of the appropriate regulations, legislation and guidance relating to clinical research.
Desirable criteria
- Proven experience of managing, conducting and reporting audits.
- Experience of undergoing inspection and audit by an external authority.
- Experience of previous training in monitoring of clinical research studies.
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