Guy’s and St Thomas’ is among the UK’s busiest and most successful NHS foundation trusts. We provide a full range of hospital and community services for people in south London and as well as specialist care for patients from further afield including cancer, renal, orthopaedic, respiratory and cardiovascular services. Guy’s is home to the largest dental school in Europe and a £160 million Cancer Centre opened in 2016. As part of our commitment to provide care closer to home, in 2017 we also opened a cancer centre and a kidney treatment centre at Queen Mary’s Hospital in Sidcup. St Thomas’ has one of the largest critical care units in the UK and one of the busiest emergency departments in London. It is also home to Evelina London Children’s Hospital. Evelina London cares for local children in Lambeth and Southwark and provides specialist services across south east England including cardiac, renal and critical care services. We lead a number of specialist service networks aiming to ensure children are treated locally where possible, but have access to specialist expertise when they need it. Our community services include health visiting, school nursing and support for families of children with long-term conditions. Our adult community services teams deliver care at the heart of the local communities we serve, working in partnership with GPs, local authorities and other healthcare and voluntary sector organisations. Working with our partners in Lambeth and Southwark, we are focusing on new ways of working to improve care for local patients. In February 2021 the Royal Brompton and Harefield joined Guy’s and St Thomas’ NHS Foundation Trust, bringing together world-leading expertise in the care and research of heart and lung disease. Our merger provides a once in a generation opportunity to build a lasting, world-renowned heart and lung centre, providing the highest quality care for patients and conducting world-leading research. We have a reputation for clinical excellence and high quality teaching and research. We are part of King’s Health Partners, one of eight accredited UK academic health sciences centres. In partnership with King’s College London we have dedicated clinical research facilities including an MHRA accredited Phase I clinical trials unit. Patients are at the heart of everything we do and we pride ourselves on ensuring the best possible patient experience as well as safe, high quality care. We are proud to have one of the lowest mortality rates in the NHS. Following a comprehensive Care Quality Commission (CQC) inspection in 2019 we maintained our overall rating of ‘good’. Our adult community services achieved a rating of ‘outstanding’. The commitment of our 23,500 staff is key to our success. We are one of the largest local employers and we aim to develop and support all our staff so they are able to deliver high quality, safe and efficient care. The 2019 NHS staff survey results show that we have one of the most engaged and motivated workforces in the NHS. We know this has a positive impact on the care provided to our patients. We have one of the most ambitious capital investment programmes anywhere in the NHS. Job overview 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. Main duties of the job 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. Working for our organisation 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 16 th Floor 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. Detailed job description and main responsibilities 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. Person specification Qualifications Essential criteria Educated to at least degree level preferably in a related subject area, e.g. a life science or clinical subject Evidence of ICH GCP Audit and Monitoring Training Desirable criteria Computer Systems Validation qualification Experience Essential criteria Monitoring and auditing, co-ordination or managing clinical trials to GCP in pharmaceutical company, contract research organisation, NHS or academic setting. Risk and incident management experience in the NHS or pharmaceutical industry environment Experience of managing a team Desirable criteria Experience of research across a range of therapeutic areas including first in human and phase I, device trials Skills, Knowledge & Abilities Essential criteria Strong ability to build successful relationships, influence and collaborate in a cross functional team and maintain a positive work environment with GST and KCL colleagues Ability to communicate complex information to members of the team and groups of health service staff Strong ability to problem solve Guy’s and St Thomas’ celebrates, respects and values the diversity of its staff and patients. We review our policies, procedures and practices to ensure that all employees, patients and carers are treated equitable according to their needs. We are actively committed to ensuring that no one who applies for a job, works or study’s at the Trust, or accesses our services is discriminated against on the grounds of race, ethnicity, nationality, disability, religion or belief, age, gender identity , gender reassignment, sexual orientation, pregnancy and maternity/paternity, or marital/civil partnership. Applications are welcomed from applicants with a disability. We can make reasonable adjustments and offer support and advice in a variety of ways throughout the application process. Equality of opportunity is our policy. As an organisation we are committed to developing our services in ways that best suit the needs of our patients. This means that some staff groups will increasingly be asked to work a more flexible shift pattern so that we can offer services in the evenings or at weekends. Flexible working We are committed to supporting all employees to achieve a healthy work life balance and to work in a way that is best for them and our patients. We will consider all requests to work flexibly, taking in to account the individual’s personal circumstances as well the needs of the service. We encourage all prospective applicants to discuss their individual circumstances with the recruiting manager as part of the on-boarding process. Your e-mail address is important to us - We communicate to all job applicants via the e-mail address which has been provided on the application form. Please ensure that you check your e-mail on a regular basis. Please apply for this post by clicking "Apply Online Now." Further details / informal visits contact Name Rachel Fay Job title Research Governance Manager Email address [email protected] Telephone number 020 7188 7188 Additional information Please contact via email only for further information and informal discussions about this new role. Please note we cannot accept CVs.