CRF QA Manager

Job overview

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 post holder will make autonomous professional decisions on a daily basis relating to the initiation, development and implementation of quality assurance systems in the CRF.

The post holder will have responsibility for supporting the strategic objectives of the BRC.

Main duties of the job

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.

Detailed job description and main responsibilities

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.

Applicant requirements

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.