R&D Auditor and Research Compliance Manager | Guy's and St Thomas' NHS Foundation Trust

The post holder will develop, implement and maintain sponsor oversight management systems, including audits plans, to assure the quality of clinical research sponsored or co-sponsored by GSTT is in accordance with prevailing legislative and best practice requirements, including Good Manufacturing Practice, Good Laboratory Practice principles, the UK Policy for Health and Social Care, ICH 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.

You will be an experienced ICH-GCP research auditor, who is an expert in sponsor oversight management systems (e.g. audit plans, monitoring, trial committees, research databases, risk-assessments) who will further develop the quality management systems of clinical research sponsored or co-sponsored by GSTT. To do this you will be knowledgeable of research funding, approvals process and the regulations of clinical trials in the UK.

As a research audit lead the post-holder will work autonomously and collaborate with other QA and clinical trial management professionals, across the trust, university and KHP Clinical Trials Office. Working in a complex organisation with multiple partners and competing pressures, you must be able to influence change, negotiate and act with diplomacy to improve quality standards.

This is a dynamic, lively and diverse department with a high- level of research activity who look forward to welcoming a new Quality Assurance expert in our team.

This is a part-time job: 0.8 WTE (30 hours or 4 days a week). We are open to flexible working arrangements such as compressed hours in line with the Trust Flexible working policy. However, the post-holder will be required to work in the R&D office at Guy's hospital a minimum of one day a week and as a senior member of the R&D office may on occasions be required to attend more frequently to support the team and when conducting on-site audits. The R&D office on the 16thFloor Guy's Tower will work across all hospital sites within the organisation and across KCL campuses. The post-holder will be required to visit other UK research sites and organisations e.g. CTUs and labs to conduct on-site audits.

The post-holder will develop, implement and maintain a clinical trial and GCP audit and monitoring programme, improving the R&D Quality Management System (QMS) with a particular focus on studies that are sponsored/co-sponsored by GSTT. This will include risk-assessments at grant stage and supporting the R&D sponsorship team of risk management during the set-up process. Responsibilities will include incident and breach management, CAPA, the establishment of sponsor oversight mechanism for third-parties e.g. selected CTUs and vendors, report and SOP and guidance document writing.

Along with in-depth technical knowledge about clinical trials, ICH-GCP and their regulations, the post-holder will have experience in trial monitoring and/or GCP auditing, change-management and be a skilled influencer who will collaborate with professionals at all levels including senior clinical investigators, KHP CTO, R&D clinical trials management platform, KCL RMID and RGO research delivery managers and staff and the wider R&D office. This is an exciting opportunity to promote and lead quality research culture across a complex organisation.