Oncology Haematology Clinical Trial Set-up
7 months ago
As Set-Up Specialist, you will play a crucial role in the initiation and set-up of commercial and non-commercial clinical trials within OHCT. Working with the OHCT Research Business Development and Initiation Manager, you will be responsible for ensuring feasibility, reviewing clinical trial budgets, conducting financial negotiations with commercial and non-commercial sponsors, ensuring the financial viability of trials. Your primary focus will be on driving the efficient and timely set-up of clinical trials collaborating closely 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. Alongside set-up, this post will oversee coordination of amendments for the department ensuring they are correctly tracked, processed and implemented within appropriate timeframes. This role will also oversee line management of the OHCT Imaging Coordinator and Data Managers, and delivering training on topics related to trial set-up.
- To have input into the feasibility process to ensure viability of new clinical trials - To work closely with KHP-CTO and Trust R&D as required to ensure the timely set-up of commercial and non-commercial clinical trials. - To conduct reviews of commercial clinical trial budgets ensuring financial viability - To conduct reviews of non-commercial agreements and the Schedule of Events Cost Attribution Template (SoECAT) - To work with Trust R&D to complete confirmation of capacity and capability assessments for the set-up of non-commercial clinical trials. - To undertake financial negotiations with commercial companies, clinical research organisations and Trust Investigators. - To identify and liaise with necessary support departments to confirm capacity to support OHCT trials and collect relevant costs and documentation. - To coordinate with support departments, research teams, investigators and Trust R&D/KHP-CTO to ensure trials are opened to pre-agreed time and target. - To line manage and coordinate the workload of the OHCT Imaging Coordinator and Data Managers - To lead clinical trial set-up training and model practices to OHCT staff members and external team members (where required). - To assist with collection of KPIs/Metrics - To oversee, track and ensure timely processing and implementation of amendments for the department. - To attend and contribute to relevant meetings
The Oncology and Haematology Clinical Trials (OHCT) team is made up of eighty plus staff members consisting of Research Nurses, Clinical Trial Practitioners, Clinical Trial Coordinators and the Safety & Support Team at Guys’ and St Thomas’ NHS Foundation Trust. We work closely with the oncology and haematology medical teams to recruit patients to our trials and to ensure patients are monitored closely throughout. We have a large portfolio of Phase II and III trials; which are split into teams for specific tumour groups. We also have a team dedicated to early phase trials and run weekly early phase clinics in the Clinical Research Facility. We attract commercial and non-commercial trials, ranging from interventional drug or radiotherapy trials to observational studies. Our mission statement is ‘Improving treatment choice, clinical care and outcomes for cancer patients through innovation, dedication and excellence in clinical trials’.
A detailed job description, person specification and functional requirements for the role are available in attached documents.
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