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CRF Quality Assurance / Administration Officer

Band 5

Main area
Clinical Research Facility (CRF)
Band 5
Fixed term: 1 year
Full time: 37.5 hours per week
Job ref
Southampton General Hospital
£24,907 - £30,615 per annum
Salary period
27/01/2021 23:59
Interview date

We are looking for a highly motivated, enthusiastic and experienced Quality Assurance Officer to join us in the development of the CRF based at the Southampton General Hospital.

To assist in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the CRF, in accordance with a variety of regulatory Statutes, guidelines and protocols as required by the by the Medicines and Healthcare Products Regulatory Agency (MHRA), the Health & Safety Executive, the Human Tissue Authority and other regulatory agencies.

Assist the CRF Quality Assurance Lead responsibility for Governance and Quality Assurance (QA) initiatives linked to the research programmes to ensure that the WTCRF and BRUs meet accreditation standards for the conduct of Phase I clinical trials.  This work is to be carried out locally in collaboration with R&D RG&QA Manager, CRF Matron and Operations Managers and nationally within the QA group of the Clinical Research Facilities UK Network.

This is an exciting and excellent opportunity to join a vibrant team with extensive expertise in clinical research.

The post-holder will join a friendly, supportive and growing research service that values the contribution of all staff.


The Research Facility and its award winning teams bring exciting research opportunities to the UHS for the benefits of patients and future Healthcare.

You will join an enthusiastic, driven and caring research admin team in a friendly, professional working environment.

This post will involve working Monday to Friday 8.30 – 16:30 a total of 37.5 hours a week.


  • To support the Senior QA Lead / Manager in the development, implementation and maintenance of systems to assure the quality of clinical research undertaken within the Clinical Research Facility (CRF), in accordance with relevant legislation, for example the International Conference on Harmonisation Good Clinical Practice Guidelines (ICH-GCP) , the UK Policy Framework for Health and Social Care Research (2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004 and amendments.
  • To support the CRF preparation for external audit and regulatory inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA).
  • To assist in the delivery of QA initiatives to ensure that the CRF meets required standards for the conduct of clinical research with special emphasis on early Phase studies.
  • To assist and work with the CRF Operations Manager for recording and collating information for a Study Excel database, using analytical skills to interpret metrics information required for annual reporting methods.


  • Proven experience of developing and implementing quality assurance procedures.
  • Proven project or administrative management with good organisational skills.
  • Awareness of ICH GCP (International Conference on Harmonisation Good Clinical Practice).
  • Awareness of the major regulatory issues governing the conduct of clinical research
  • Knowledge of the appropriate regulations, legislation and guidance relating to clinical research.
  • Excellent communication and interpersonal skills (oral, written & presentation).
  • Self-motivated and able to work independently or as part of a team.
  • Organised with good time management skills.
  • Strict attention to detail.
  • Diplomatic and calm under pressure.


As one of the largest acute teaching Trust’s in England, we can offer learning and development opportunities to help you achieve the career you aspire to. We believe you deserve the best possible surroundings in which to do your job and we want to support you in doing your job to the best of your ability.

As a Trust, we support flexible working and will consider requests taking into account the needs of the service. You’ll have an opportunity to discuss this at interview. Our LiveWell and inspire programme offers opportunities, support and advice, including smoking cessation services, exercise and activity classes, and support for mental health.

UHS employees are able to access a huge range of NHS discounts, are entitled to a minimum of 35 days paid holiday (pro rata) on appointment, can access on-site nursery facilities (subject to availability), and we offer a generous pension scheme.


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. 

Southampton is an attractive place to live and work situated on the south coast, with an international airport and only an hour on the train from central London. The New Forest National Park and the beaches of the Jurassic coast are also right on our doorstep. The city offers living costs 20% lower than those in London, 13 schools rated outstanding by Ofsted and 13 nearby green spaces to enjoy.


Interviews will be held on Wednesday, 10 February 2021.


If you’re interested in applying for this role, we’d encourage you to get in touch using the contact information at the bottom of this advert with any questions or if you would like to arrange an informal visit. Alternatively, if you’re ready to apply, please follow the link below to complete an application.

Apprenticeships logoNo smoking policyDisability confident employerCare quality commission - Good

Documents to download

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Further details / informal visits contact

Kim Lee
Job title
Senior QA Lead
Email address
Telephone number
023 8120 4989

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