CRF QA Manager


Company:	NHS Jobs
Salary:	£58,133 to £65,261 a year
Hours:	Full-time
Location:	London, SE5 9RS
Job type:	Permanent
Posting date:	5 Oct 2026
Closing date:	18 Oct 2026

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Summary

Management of Quality Assurance in the Clinical Research Facility Manage and maintain the quality control of clinical research activity undertaken within the CRF. Ensure that all changes to existing working practices and the introduction of new working practices and policies are implemented in the CRF using robust and standardised systems. Develop, implement, review and verify CRF working practices and standard operating procedures, ensuring that all Regulatory, College and Trust requirements are encapsulated. Maintain precise and accurate quality management records that are ready for inspection by regulatory authorities and Sponsors on demand. Recognise and respond to research governance and quality issues that might arise during quality control checks. Review and risk assess the CRFs clinical trial portfolio in order to identify high-risk studies and target the use of Quality Control systems Recognise and act upon departures from legislative and research governance requirements including failure to follow protocols and or SOPs, responding appropriately and escalating action as required. Participate in regulatory inspections and audits as required Lead the preparation for mandatory inspection of the CRF by the MHRA, developing and maintaining an inspection implementation plan, in order to ensure that the CRF remains in a state of readiness for statutory inspection. Act as the primary contact person for regulatory agencies during mandatory inspections of the CRF, accompanying the inspectors, responding promptly to requests for information and ensuring that designated staff is available for interview as required. Review any inspection findings, taking responsibility for coordinating remedial action, ensuring completion of tasks and attainment of requisite regulatory standards. Develop tools to permit review of results of quality control checks and develop Key Performance Indicators and metrics to ensure quality at all times. Lead on the maintenance and further development of a comprehensive suite of Standard Operating Procedures, working practices and guidance documents that are compatible with KHP quality systems to ensure a robust quality system within the CRF. Promote a Quality Culture among CRF staff, users and the wider clinical research community. Implement and maintain a document management system, ensuring that CRF policies, Standard Operating Procedures (SOPs) and essential study documents are updated and controlled according to regulatory requirements. Maintain robust CRF systems to protect the rights of subjects involved in research (in accordance with the Data Protection Act, Human Rights legislation and ICH GCP) acting to prevent the disclosure of sponsors proprietary information or subjects identity to other than authorised individuals. Manage and monitor CRF systems for recording and reporting adverse events / adverse reactions to the sponsor, ensuring that the investigator provides all necessary reports, submissions and notifications for the attention of regulatory authorities. Information Management The post holder will use standard information technology - Word, Excel, Access, internet Explorer and the CRF specific software in order to undertake their duties. They will act as administrator for the CRF Quality Management System- QPulse. They will also use the Trust reporting systems across KCH and SLAM (EPJs, EPR, Datix etc) and other relevant reporting systems They will manage the storage and archiving of CRF records in accordance with the Trust, R&D and KCH Clinical Trials Office processes and SOPs.

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