Overview
Guy's and St Thomas' NHS Foundation Trust is among the UK's busiest and most successful NHS trusts, providing a full range of hospital and community services in south London with specialist care across 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. In 2017 a cancer centre and a kidney treatment centre were opened at Queen Mary's Hospital in Sidcup. St Thomas' has a large critical care unit and one of the busiest emergency departments in London, and Evelina London Children\'s Hospital is part of the trust. Evelina London cares for local children and provides specialist services across south east England.
Our adult community services work with GPs, local authorities and other partners to improve local care. In February 2021 the Royal Brompton and Harefield joined Guy\'s and St Thomas\'s NHS Foundation Trust to form a leading heart and lung centre. We are part of King\'s Health Partners, with dedicated clinical research facilities and a strong focus on teaching, research and patient care.
We emphasise patient experience and safety, with a track record of high-quality care and research excellence. The trust employs around 23,500 staff and has a broad capital investment programme. We are committed to equal opportunities and inclusive working practices.
Job overview
As a Clinical Trial Set-Up Specialist, you will play a crucial role in leading the initiation and set-up of commercial and non-commercial clinical trials within OHCT. You will ensure feasibility, review clinical trial budgets, conduct financial negotiations with sponsors and CROs, and secure the financial viability of trials. Your primary focus will be on driving efficient and timely set-up of trials, collaborating with the King\'s Health Partners Clinical Trials Office (KHP-CTO), Guy\'s and St Thomas\' R&D, support departments, research teams and investigators to meet timelines and targets. The role also oversees coordination of amendments, line management of the OHCT Imaging Coordinator and Roving Data Managers, and delivery of training related to trial set-up.
Main duties of the job
- Work autonomously to manage the feasibility and set up of a large portfolio of commercial and non-commercial trials
- Input into the feasibility process to ensure viability of new clinical trials, including attendance at site selection visits, assisting with feasibility questionnaires and contributing to Trials Adoption Feasibility Forms (TAFFs)
- Review and develop systems to aid the negotiation of commercial contracts in relation to clinical departments such as pharmacy, pathology, radiology
- Collaborate with KHP-CTO and Trust R&D to ensure timely set-up of trials
- Coordinate submissions for Ethics Committee/R&D Committee/Joint Clinical Trials Office approvals and ensure compliance with the Research Governance Framework
- Identify bottlenecks and opportunities for improvement in trial initiation and management
- Act as a resource for research staff on regulatory and approval matters
- Communicate with internal and external groups to provide advice and interpretation of complex business information
Working for our organisation
Guy\'s and St Thomas\' NHS Foundation Trust comprises five hospitals and associated community services, with a strong history of care, research and innovation. As part of King\'s Health Partners we are an academic health sciences centre with dedicated clinical research facilities. The Oncology and Haematology Clinical Trials (OHCT) team consists of 70+ staff, collaborating with medical teams to recruit patients and monitor trials across Phase II/III and early-phase studies, including interventional and observational studies.
We recruit patients to trials and ensure close monitoring, with a team structure that includes clinical trial nurses, practitioners, coordinators, data managers, and the Safety & Support Team. We seek to attract commercial and non-commercial trials and maintain a robust portfolio.
Detailed job description and main responsibilities
Trial Set-Up
- Input into the feasibility process to ensure viability of new clinical trials, including attendance at site selection visits, assistance with feasibility questionnaires and input into TAFFs
- Review and develop systems to aid the negotiation of commercial contracts with clinical departments
- Work closely with KHP-CTO and Trust R&D to ensure timely set-up of trials
- Conduct reviews of trial budgets for financial viability and reviews of non-commercial agreements (including SoECAT) with the Research Business Development and Initiation Manager
- Coordinate with Trust R&D to complete confirmations of capacity and capability for non-commercial trial set-up
- Undertake financial negotiations with commercial sponsors, CROs and investigators
- Build relationships with stakeholders to ensure smooth trial set-up and liaise with support departments for capacity and costs
- Collaborate with trial teams to open trials to pre-agreed timelines; assist with investigator-led trial set-up and research agreement development
- Lead on training and development of OHCT staff in trial set-up practices
- Lead and support staff in the management support team as an expert resource
Management and Leadership
- Motivate, develop and support department staff; manage sickness, capability and disciplinary matters in liaison with HR
- Agree study and annual leave requirements and provide cover as needed
- Contribute to yearly business planning and act as a role model for research delivery
- Line manage the OHCT Imaging Coordinator and data managers; provide guidance on commercial and non-commercial trial set-up
- Lead clinical trial set-up training and model best practices
Research Management
- Coordinate submissions for Ethics/R&D/Joint Clinical Trials Office approvals and ensure compliance with Research Governance Framework
- Identify bottlenecks and areas for improvement in trial initiation and management
- Oversee, track and implement amendments; attend relevant research team and sponsor meetings as required
- Lead on primary and secondary research, audits and evaluations
- Assist with projects and lead data collation from trials
- Build strong professional relationships with other departments to promote collaboration
Communication and Information Management
- Communicate with internal and external groups to provide adice and interpretation of complex data
- Use persuasion and negotiation to secure information under deadlines
- Attend meetings with senior staff to present data and support business cases
- Provide first point of contact for a range of business initiatives
- Promote the work of the research team and disseminate publications
- Assist with IT systems implementation to support research processes and trials
Professional Development
- Attend training and development days as agreed, and keep up to date with professional development and research
- Undertake regular performance reviews and adhere to trust policies
Person specification
Knowledge/Qualifications
Essential criteria
- Master\'s degree in life sciences or related field or demonstrable equivalent knowledge/experience
- GCP certificate
- Evidence of continuous professional development
Desirable criteria
- Teaching experience
- Project Management Qualification (e.g., PRINCE2)
Previous experience
Essential criteria
- Significant experience in clinical research coordination and managing own portfolio of studies
- Experience in running clinical trials including budget negotiations and liaising with external departments
- Experience mentoring, developing and supervising junior staff
- Experience teaching, assessing and supervising others
- Experience managing complex projects
Desirable criteria
- Experience in oncology and haematology clinical services
- Demonstrable managerial/team lead experience
- Experience of financial management
Skills
Essential criteria
- Excellent communication and interpersonal skills; ability to develop relationships with staff and external bodies
- Ability to provide highly specialist advice; awareness of changing trends in research and clinical trials
- Up-to-date knowledge relevant to clinical research and good clinical practice
- Ability to set direction, prioritise and meet deadlines
- Analytical and judgement skills; ability to interpret complex data
- Ability to lead, teach, supervise and mentor others in clinical research delivery
- Confident and articulate; able to negotiate in complex situations
- Strong presentation skills
Desirable criteria
- Ability to carry out audits
Additional Information
Essential criteria
- Flexible and positive approach to work
- Highly motivated and enthusiastic
Equality and flexibility statements
Guy\'s and St Thomas\'s celebrates diversity and is committed to equal opportunities. We welcome applicants with disabilities and will provide reasonable adjustments in the application process. We may require flexible shift patterns to meet service needs.
Flexible working We are committed to supporting work-life balance and will consider flexible working requests. Please discuss individual circumstances with the recruiting manager.
Note: Due to UK immigration rules, ensure you meet the requirements to live and work in the UK before applying. Further information is available on the UK Government website.
Your e-mail address is important to us. Please check your email regularly. Please apply for this post by clicking "Apply Online Now."
Documents to download
- SUS JD/PS (PDF, 272.4KB)
- FRF (PDF, 368.6KB)
