Clinical Trials Start Up Specialist

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 be responsible for ensuring feasibility, reviewing clinical trial budgets, conducting financial negotiations with commercial and non-commercial sponsors and Contract Research Organisations (CROs), and ensuring the financial viability of trials. Your primary focus will be on driving the 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 team and investigators to meet established timelines and targets. You will oversee coordination of amendments for the department to ensure they are tracked, processed and implemented within appropriate timeframes. This role will also oversee line management of the OHCT Imaging Coordinator and Roving Data Managers and deliver training on topics related to trial set-up.

Working for our organisation: Guy's and St Thomas' NHS Foundation Trust comprises five of the UK's best known hospitals and has a long history of high quality care, clinical excellence, research and innovation. As part of King's Health Partners, we are one of England's eight academic health sciences centres with dedicated clinical research facilities.

• 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 and input at site selection visits, assisting with feasibility questionnaires, and input into Trials Adoption Feasibility Forms (TAFFs).
• Review and develop systems to aid the negotiation of commercial contracts related to clinical departments such as pharmacy, pathology, and radiology.
• Collaborate with KHP-CTO and Trust R&D to ensure timely set-up of commercial and non-commercial clinical trials.
• Coordinate submissions for Ethics Committee, R&D Committee, Joint Clinical Trials Office approval, and ensure alignment with the Research Governance Framework for trials.
• Identify bottlenecks and inefficiencies in trial initiation and management, and propose improvements.
• Act as a resource for research staff on regulatory and approval matters.
• Communicate with internal and external groups to provide advice, guidance and interpretation of complex business information and data requirements.

• Lead and support staff within the management support team as an expert resource, demonstrating tenacity, drive, integrity, balance and perspective.
• Motivate, develop, support and identify training needs for department staff and contribute to the department training programme.
• Implement HR policies on staffing matters, address sickness, capability and disciplinary issues in liaison with HR and the Management Team.
• Agree the team's study and annual leave requirements and provide cover for annual, study and sick leave.
• Contribute to yearly business planning with the service management team.
• Line manage the OHCT Imaging Coordinator and a team of data managers, coordinating workload with team leads.
• Provide support and guidance to team members on all aspects of commercial and non-commercial trial set-up.
• Lead clinical trial set-up training and model practices for OHCT staff and external teams as required.

• Coordinate submissions for Ethics Committee/R&D Committee/Joint Clinical Trials Office approvals and ensure compliance with the Research Governance Framework.
• Identify bottlenecks and areas for improvement in trial initiation and management.
• Oversee, track and ensure timely processing and implementation of amendments for the department.
• Act as a resource for research staff on regulatory and approval matters.
• Attend and contribute to relevant research team monthly meetings, OHCT Adoption and Feasibility Committee meetings and sponsor meetings as required.
• Lead on primary and secondary research, audits and evaluations as required.
• Assist the Research Business Development and Initiation Manager with projects as required.
• Lead on data collation, including accrual data generated from clinical trials.
• Build strong professional relationships with other departments to promote a collaborative working environment.

• Communicate with a range of internal and external groups to provide advice, guidance and interpretation of complex information and data requirements.
• Use persuasion and negotiation to secure information within competing deadlines.
• Attend meetings with senior staff to present data, answer questions, and strengthen business cases.
• Provide first point of contact for range of business initiatives.
• Promote the work of the research team and disseminate publications and information material.
• Assist with the setup and implementation of IT systems in support of research processes and trials, in collaboration with Trust IT and sponsors.

• Attend training programmes and relevant education as agreed in development plans.
• Take responsibility for personal professional growth and stay updated with professional development and research.
• Undertake regular performance reviews and ensure adherence to trust policies within the team.

Equality, diversity and flexible working: Guy's and St Thomas' NHS Foundation Trust is committed to equal opportunity and a diverse workforce. We encourage applications from disabled applicants and will provide reasonable adjustments as needed. We support flexible working arrangements where possible and provide guidance on eligibility for UK immigration requirements as applicable. Please apply online. AfC: Band 7.