Job Description

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.



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.



King's College Hospital NHS Foundation Trust is one of the UK's largest and busiest teaching Trusts with a turnover of c1.8 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.



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.