About the role
Salary: £58133.00 to £65261.00
The post holder will maintain systems to assure the quality of clinical research undertaken within the Clinical Research Facility in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the Research Governance Framework for Health and Community Care 2005, Good Clinical Practice as defined in the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act. The post holder will play a key role in the co-ordination of working practices and policy implementation to ensure that the Clinical Research Facility is at all times compliant with both internal policies and external regulatory frameworks. They will have an expert knowledge of those regulatory frameworks and will be able to liaise at a high level with all stakeholders within KHP. The post holder will be based at the Denmark Hill CRF but will be expected to work closely with the counterparts at the Guy's and St Thomas' across both CRFs.
The postholder will lead and maintain the CRF's quality assurance and management systems, ensuring compliance with regulatory, Trust and research governance requirements. They will develop and review SOPs, policies and working practices, monitor and risk-assess the clinical trial portfolio, identify and address quality and governance issues, and maintain accurate records. The postholder will also lead inspection readiness and support MHRA, regulatory and Sponsor inspections, coordinate responses to findings and remedial actions, and use quality metrics and KPIs to drive continuous improvement across the CRF.
Management of Quality Assurance in the Clinical Research Facility