Clinical Trials Start Up Specialist
| Dyddiad hysbysebu: | 08 Hydref 2025 |
|---|---|
| Cyflog: | £56,276.00 i £63,176.00 bob blwyddyn |
| Gwybodaeth ychwanegol am y cyflog: | £56276.00 - £63176.00 a year |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 22 Hydref 2025 |
| Lleoliad: | London, SE1 9RT |
| Cwmni: | NHS Jobs |
| Math o swydd: | Cytundeb |
| Cyfeirnod swydd: | C9196-25-1665 |
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Trial Set-Up To have input into the feasibility process to ensure viability of new clinical trials being brought into the department including attendance and input at site selection visits, assistance with feasibility questionnaires as required and input into Trials Adoption Feasibility Forms (TAFFs). Review and develop, as necessary, systems to aid the negotiation of commercial contracts in relation to clinical departments such as pharmacy, pathology, radiology. 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 from an OHCT perspective based on consideration of the trial protocol, discussions with investigators regarding resource implications, set-up fees and external department utilisation. To conduct reviews of non-commercial agreements and the Schedule of Events Cost Attribution Template (SoECAT), working with the Research Business Development and Initiation Manager to review funding. 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 as necessary. To build working relationships with key stakeholders to ensure smooth running of the trial set-up process. To identify and liaise with necessary support departments to confirm capacity to support OHCT trials and collect relevant costs and documentation as required for trial governance during set-up. 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 assist the Research Business Development and Initiation Manager with Investigator-Led clinical trial set-up and development of research agreements. Management and Leadership Lead and support staff within the management support team acting as an expert resource, demonstrating tenacity, drive, professional integrity, balance and perspective. Motivate, develop, support and identify training needs for department staff and take a proactive role in the department training programme Implement and work within the Trusts HR policies on all staffing matters, including sickness, capability and disciplinary issues. Take corrective measures if indicated in liaison with Human Resources and the Management Team. Agree the teams study and annual leave requirements and provide cover when necessary for annual leave, study leave and sick leave. To contribute to yearly business planning in conjunction with the service management team. Act as a role model for excellence in research delivery To line manage and coordinate the workload of the OHCT Imaging Coordinator To line manage team of data managers and work with relevant team leads regarding their allocation. To provide support and guidance to team members on all aspects of commercial and non-commercial clinical trial set-up. To lead clinical trial set-up training and model practices to OHCT staff members and external team members (where required). Research Management Co-ordinate submissions for Ethics Committee/R&D Committee/ Joint Clinical Trials Office approval for commercial and investigator-initiated trials and ensure that all the requirements of the Research Governance Framework are met for those trials. To identify bottlenecks, inefficiencies, and areas for improvement in trial initiation and management. To oversee, track and ensure timely processing and implementation of amendments for the department. To act as a resource for research staff concerning regulatory and approval matters. To attend and contribute to relevant research team monthly meetings, OHCT Adoption and Feasibility Committee meetings and Sponsor meetings (where required). To lead on primary and secondary research, audits and evaluations as required. To assist the Research Business Development and Initiation Manager with projects as required To lead on the collation of data, including accrual, generated from clinical trials. Build strong professional relationships with other departments in order to promote a good working environment. Communication and Information Management Communicate with a range of internal and external groups and individuals to provide advice, guidance and often interpretation of complex business information and data requirements Use persuasion and negotiation to secure information in line with competing deadlines Attend a range of meetings with senior staff to present data or information gathered, take questions or find further information to strengthen business cases Provide first point of contact for a range of business initiatives Promote the work of the research team and disseminate publications and information material Assist with the set up and implementation of appropriate IT systems in support of the research processes and trials, in conjunction with local Trust IT departments and the research sponsors Professional Development Attend the training programmes and other relevant education and training days as agreed in your development plan. Take personal responsibility for own professional growth and keep up to date with professional development and research. Undertake performance review at regular intervals. Ensure adherence to trust policies throughout the team