About this role
Job summary
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.
About us
As one of the largest acute teaching Trusts in England, we offer learning and development opportunities to help you achieve the career you aspire to. UHS is rated 'Good' by the CQC and in the latest national NHS Staff Survey, we were in the top 10 acute trusts for staff engagement and for staff recommending the hospital as a place to work or receive care.
We support flexible working and will consider requests taking into account the needs of the service. UHS employees are able to access a range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata), and we offer a generous pension scheme.
Southampton is an attractive place to live and work situated on the south coast, with an international airport and direct trains to London. The New Forest National Park and beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 30% lower than London and 17 schools rated outstanding by Ofsted.
We believe that using technology wisely shows strong time management and commitment to innovation. However, personalising your recruitment application to highlight your unique skills and experiences is crucial. Relying too heavily on generic, AI-generated content instead of drawing from your own strengths and accomplishments may lead to your application being rejected if multiple candidates present identical or similar information.
Job description
Job 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 YOULL 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.
WHAT WERE 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
- 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
- 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.
Trust Values
Essential
- Patients First
- Always Improving
- Working Together
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.
Certificate of Sponsorship
Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
Employer details
Employer name
University Hospital Southampton NHS Trust
Address
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Employer's website
https://www.uhs.nhs.uk/home.aspx (Opens in a new tab)