Quality Assurance OfficerNHS
Job summary
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.
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.
Main duties of the job
- In conjunction with the QA Team and R&D Operational Manager, set up and manage the quality control of clinical research activity undertaken within the R&D Office.
- Support the QA Team to develop, implement, review and verify R&D working practices and standard operating procedures, ensuring that all Regulatory 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.
Job description
- Preparing reports of InPhase incidents across the Trust for the Research Governance and Risk committee on a quarterly basis.
- In conjunction with the QA team monitor incidents to ensure CAPA has been implemented and incidents are closed.
- Working with patient safety managers to ensure close links between Trust and research governance systems .
- Assist in the hosting of regulatory inspections and external audits as required.
- In conjunction with the QA Team, manage the Trusts research audit and monitoring programme and undertake monthly GCP and research governance audits and writing reports. 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.
Please refer to the attached job description and person specification for further details of the main responsibilities of the role.
About us
The Trust provides a full range of local and specialist services across its five sites. In June 2026, we launched our new strategy for 2026-31. Our vision is to transform healthcare, and we have agreed six strategic ambitions to help us improve care for patients, and the working lives of our staff.
Our six strategic ambitions are deliveringhigh-quality patient care; creating a great place to work; leading pioneering research, innovation and education; building strong and successful partnerships; providing timely and efficient care; and ensuring long-term financial sustainability.
We have also agreed four new organisational values - Caring, Collaborative, Inclusive, Innovative - and these underpin everything we do, and how our teams interact with the patients under our care.
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.
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