CRF Quality Assurance Manager
| Posting date: | 29 April 2025 |
|---|---|
| Salary: | £54,320.00 to £60,981.00 per year |
| Additional salary information: | £54320.00 - £60981.00 a year |
| Hours: | Full time |
| Closing date: | 12 May 2025 |
| Location: | London, SE5 9RS |
| Company: | NHS Jobs |
| Job type: | Permanent |
| Job reference: | C9213-25-0486 |
Summary
Management of Quality Assurance in the Clinical Research Facility To oversee and ensure that the Vertical Laminar Flow Cabinet (VLFC) is fully operational and its operators are trained in aseptic techniques as well as supervise all training until the staff member is competent. To ensure that all staff performing tasks within the VLFC have completed and passed a Broth and Operator Transfer Disinfection validation. To perform all pre-sessional environmental and microbiological monitoring and to liaise with CTU team to obtain these test results prior to IMP preparation within the VLFC. To ensure that all the equipment is serviced and calibrated regularly at a period of once every 12 months by the manufacturer (Monmouth Scientific). To ensure that subsequent PQs are performed each year. To ensure that all calibration and validation (Installation Qualification, Operational Qualification and Performance Qualification), results are stored and recorded on QPulse. Oversee and monitor systems for the procurement, processing and storage of biological samples ensuring that such activity is undertaken within the terms of Human Tissue legislation, ethical approval and the necessary requirements of the research protocol, in order to make certain that safe handling, ethical integrity and quality is assured. Oversee and record annual systems tests e.g. emergency evacuation procedure, identifying any system failures and acting to resolve them, in order to demonstrate that the CRF meets the required safety standards for hosting clinical research studies Organise and conduct mock inspections of the CRF, in order to check that facilities, services and staff are prepared for regulatory inspection and that individual staff members are aware of their research governance responsibilities. Prepare and present regular internal audit reports to the CRF Operational Management Team in order to ensure that the CRF Directors and Clinical Research Manager are fully appraised of any systems gaps requiring remedial action and alerted to any breaches of research governance legislation requiring corporate action. Indirectly assist clinicians in conducting high quality research which leads directly to changes in patient care, NHS services and better evidence- based practice. Act as lead Health and Safety Advisor for the CRF, ensuring that the facility is complying with all local Trust and regulatory requirements. Responsible for completing and submitting the annual Trust Health and Safety returns and for drafting and maintaining CRF Health and Safety Code of Practice and risk assessments. Attend, and contribute to regular CRF Management, Clinical Governance and Health and Safety Meetings and Trust-wide and Divisional Risk Meetings. Responsible for management of the CRF local induction and training programme for staff and users of the facility.