Quality Assurance Officer
5 months ago
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.
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.
- In conjunction with the R&D Operational Manager, recognise and respond to research governance and quality issues that might arise during quality control checks.
- Work closely with the R&D team, HTA persons designated, research managers, matrons and leads to carry out triggered audits when required.
- In conjunction with the R&D Operational Manager, manage the Trust’s research audit programme and undertake monthly GCP and research governance audits and writing reports
- Communicate effectively and calmly in difficult situations, such as those resulting from audits that recommend remedial actions.
- Recognise and respond to research governance and quality issues that might arise during quality control checks.
King’s College Hospital NHS Foundation Trust is one of the UK’s largest and busiest teaching Trusts with a turnover of c£1 billion, 1.5 million patient contacts a year and around 14,000 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 Bromley.
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.
The trust-wide strategy 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 can take Team King’s to another level.
R&D Governance and Risk
- Preparing reports of InPhase incidents across the Trust for the Research Governance and Risk committee on a quarterly basis
- In conjunction with the R&D Operational Manager, 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
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.
- They will ensure that all paper based systems are maintained securely
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