King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1.8 billion, 1.5 million patient contacts a year and more than 15,000 staff based across 5 main sites in South East London. The Trust provides a full range of local hospital services across its different sites, and specialist services from King's College Hospital (KCH) sites at Denmark Hill in Camberwell and at the Princess Royal University Hospital (PRUH) site in the London Borough of Bromley.

We encourage all our staff to have a healthy work/life balance. In doing so, you can apply for flexible working from the beginning of your employment. We offer a range of options which are designed to suit different circumstances and priorities in line with service requirements.

flexible-working

Job overview

Quality Assurance Officer - Band 5

£37,259 - £45,356 Inclusive of HCAS Per annum Pro rata

Fixed term: 12 months - Full time 37.5 hours per week

The post holder will support and maintain a quality management system to assure the quality of clinical research undertaken within the Research and Development Department in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the Research Governance Framework for Health and Social Care 2005, Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations (as amended from time to time), the Human Tissue Act, the Data Protection Act and the Mental Capacity Act.

Main duties of the job

The post holder will play a role in the co-ordination of working practices and policy implementation to ensure that the Trust is at all times compliant with both internal policies and external regulatory frameworks.

The post holder will drive a quality approach to the conduct of commercial and non-commercial clinical research to ensure that clinical trial quality is assured throughout all areas within the Trust where clinical research is undertaken.

The post holder will be based in the Trust R&D department and will work across the Denmark Hill and PRUH sites.

Working for our organisation

King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c£1.8 billion, 1.5 million patient contacts a year and more than 15,000 staff based across South East London.

The Trust provides a full range of local and specialist services across its five sites. The trust-wide strategy of Strong Roots, Global Reach is our Vision to be BOLD, Brilliant people, Outstanding care, Leaders in Research, Innovation and Education, Diversity, Equality and Inclusion at the heart of everything we do. By being person-centred, digitally-enabled, and focused on sustainability, we aim to take Team King's to another level.

We are at a pivotal point in our history and we require individuals who are ready to join a highly professional team and make a real, lasting difference to our patients and our people.

King's is committed to delivering Sustainable Healthcare for All via our Green Plan. In line with national Greener NHS ambitions, we have set net zero carbon targets of 2040 for our NHS Carbon Footprint and 2045 for our NHS Carbon Footprint Plus. Everyone's contribution is required in order to meet the goals set out in our Green Plan and we encourage all staff to work responsibly, minimising their contributions to the Trust's carbon emissions, waste and pollution wherever possible.

Detailed job description and main responsibilities

Supporting Quality Assurance and Audit Programme

• In conjunction with the R&D Operational Manager, set up and manage the quality control of clinical research activity undertaken within the R&D Office.
• Develop, implement, review and verify R&D working practices and standard operating procedures, ensuring that all Regulatory, College and Trust requirements are encapsulated.
• Implement and maintain office systems to manage working practices and policies within the Trust.
• Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand.

R&D Governance and Risk

• Preparing reports of InPhase incidents across the Trust for the Research Governance and Risk committee on a quarterly basis.
• R&D Audit Programme
  
  • Assist in the hosting of regulatory inspections and audits as required.
  • Participate in Good Clinical Practice audits of research studies running in the CRF and on occasion within the wider Trust as part of the audit programme implemented by the R&D Operational Manager.

Information and Data Management

• The post holder will use standard information technology - Word, Excel, PowerPoint, Access, Internet Explorer and the CRF specific software in order to undertake their duties.
• They will use the Trust systems - InPhase, CRF Manager, Q-Pulse, Edge and other relevant reporting systems.

Please refer to the attached job description and person specification for further details of the main responsibilities of the role.

Person specification

Education & Qualifications

Essential criteria

• Relevant degree or professional qualification or equivalent experience
• Advanced IT skills, ECDL or proven equivalent experience in MS Office, email and Internet browsers

Desirable criteria

• Good Clinical Practice training

Knowledge and Experience

Essential criteria

• Excellent oral and written communication skills to communicate effectively with researchers, consultants and staff from different disciplines and administrators at all levels
• Ability to communicate healthcare research information in an easily understood manner.
• Risk and incident management experience in the NHS or pharmaceutical industry environment.

Desirable criteria

• Basic understanding of medical terminology.

Skills and Competencies

Essential criteria

• Strong planning and organizational skills including the ability to prioritize, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria within agreed deadlines.
• Strong ability to problem solve.
• Strong ability to build successful relationships and collaborate in a cross functional team and maintain a positive work environment.
• Resilience and flexibility; able to contribute innovatively to solving process development problems.
• Well motivated with evidence of an ability to work without direct supervision and to use own initiative.
• Ability to develop and maintain good working relationships with all levels of staff
• Highly professional approach to work, in particular in dealing with confidential information.

IMPORTANT

• Check your email account regularly as this is how we will communicate with you
• If you delete the job from any of your accounts, you may be prevented from accessing further communications
• To enquire about your application or inform us of any changes in your circumstances, please contact the named person on this advert
• Please provide email addresses for referees where possible
• Click here to see the range of benefits we offer
• Please review the documentation on our recruitment microsite, particularly the Trust's criminal records checking policy
• All staff have a responsibility for safeguarding children and vulnerable adults and for ensuring they are aware of the specific duties relating to their role.
• Please note that the closing date is given as a guide. On occasion, we might close a vacancy early due to a high number of applications being received. You are advised to submit your application as early as possible to avoid disappointment.

King's College Hospital NHS Foundation Trust Annual Reports and Other Corporate Publications

King's Health Partners Academic Health Science Centre Website

King's College Hospital is part of King's Health Partners Academic Health Sciences Centre (AHSC), a pioneering collaboration between King's College London, and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts.

Employer certification / accreditation badges

Documents to download

• JD & Person Spec Research Quality Assurance Facilitator (PDF, 328.4KB)
• Denmark Hill Site Map (PDF, 1.2MB)
• Princess Royal (PRUH) Site map (PDF, 1.4MB)
• Visa and Sponsorship Information (PDF, 344.6KB)
• Pay bands and pay points from 1 April 2025 (PDF, 44.6KB)