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University College London Hospitals NHS Foundation Trust
University College London Hospitals NHS Foundation Trust (UCLH) is one of the most complex NHS trusts in the UK, serving a large and diverse population. In July 2004, we were one of the first NHS trusts to achieve Foundation Trust status.
We provide academically-led acute and specialist services, to people from the local area, from throughout the United Kingdom and overseas.
Our vision is to deliver top-quality patient care, excellent education and world-class research. We provide first-class acute and specialist services across eight sites:
The post-holder will be based at the UCL/UCLH Joint Research Office (JRO) and will act as a facilitator in the review of clinical research studies where UCLH is a participating (host) site.
The post-holder will ensure Assess, Arrange and Confirm (Feasibility) Assessments for these UCLH Hosted Studies are conducted in line with national and local procedures, expectorations and policies.
The post-holder will work with sponsors, research teams, UCLH clinical Divisions and the Local Clinical Research Network (LCRN) on conducting robust feasibility assessments which include:
- capacity and capability to participate in the study
- practical arrangements in place to provide the capacity and capability to deliver the study
The primary responsibilities include:
- Work closely with research teams, the LCRNs, legal and finance teams within the JRO, clinical research facilities and research groups and service support departments within UCLH to deliver a decision to deliver research at UCLH.
- Ensure that feasibility assessments relating to UCLH studies are conducted in accordance with national and local Standard Operating Procedures (SOPs), and time-lines.
- Ensure Sponsors and PIs are promptly provided with an outline of the requirements to conduct a study at UCLH.
- Work closely with investigators, sites and other relevant parties to formulate and oversee study set-up and delivery milestones.
- Provide expert guidance to investigators and sponsors on the requirements for UCLH Confirmation of Capacity and Capability.
- Regularly update each party with information on the progress of study approvals against agreed timelines and expectations.
- Process and approve study amendments on behalf of UCLH.
- Ensure continued monitoring and adherence to feasibility processes in accordance with JRO Key performance indicators related of research approvals.
- Brief and monitor performance of other external and internal parties involved in the set-up of the research proposals.
Key Working Relationships
The key working relationships include (although not restricted to):-
- Investigators and Research Teams from UCL and UCLH
- UCL/UCLH Service support departments
- JRO teams (Finance, Contracts, Data Management and Senior managers )
- UCLH research units/groups
- UCLH Clinical Directors
- The Health Research Authority (HRA)
- Research Funding bodies
- Other NHS and Academic organisations
- Local Clinical Research Networks (LCRNs)
- Pharmaceutical or other external companies involved in UCLH studies
Key Results Areas
Study Reviews and Expert Guidance
- Work closely with investigators, academic collaborators, clinical research fellows, nurses, and support departments to provide professional regulatory and governance advice, guidance and support.
- Provide confident advice to investigators on the regulatory and ethics requirements for the conduct of clinical research, especially the Research Governance Framework, Good Clinical Practice, data protection and the requirements of the Health Research Authority.
- Analyse and determine whether projects are compliant with current legislation, have received applicable regulatory approvals.
- Support the Principle Investigator (PI) and service support departments in confirming capacity and capability for UCLH site. Including:
- Finalise a timetable for study initiation and delivery between PI’s and sponsors.
- Ensure feasibility and study set-up procedures are conducted in line with the timelines and include all components required by the JRO, National Institute for Health Research (NIHR) and the HRA.
- Identify service support (and other) department involvement with a study and promptly initiate the service department feasibility and costing for the study.
- Verify that the PI and Sponsor have set achievable recruitment targets and timelines.
- Liaise with the PI and research team to confirm the time commitment for procedures and staff time as outlined in the costing template or schedule of activities provided by the Sponsor.
- Seek Clinical Director authorisation (in line with JRO guidance) once a feasibility assessment has been confirmed and costs have been verified.
- Work with the JRO Contracts team to ensure that clinical research contracts/agreements between the sponsor and UCLH are in place in order to protect the UCLH’s financial and legal interests.
- Work with the JRO Finance team to ensure robust and appropriate costing of UCLH Site studies is undertaken in accordance with national and local guidance.
- Early assessment of operational risks in the delivery of the study and ensure that proportionate systems are in place to manage the risks.
- Advise in cases where there are significant concerns relating to the regulatory compliance, set-up, governance or documents or risks raised by studies (prior to confirming site feasibility).
- Provide accurate briefings and support to JRO teams and external services involved in the set-up of UCLH site studies (include finance and contracts).
- Work in collaboration with the Operations team to ensure the Research Passport Scheme (in line with HRA Approval conditions) Honorary Research Contracts and Letters of Access for research staff not employed by UCLH Trust.
- Review amendments in a timely and efficient manner in accordance with local and national performance indicators; ensure UCLH still has the capacity and capability to deliver the study.
Communications and Dissemination of Information
- Ensure investigators have the necessary information on NIHR, HRA and JRO processes. This may involve presentations at academic or multidisciplinary meetings, production of website materials, and written guidance.
- Provide training on regulatory requirements and UCLH feasibility processes for research.
- Promptly answer queries, relating to legislation and the delivery of research
- Acknowledge all communication from investigators and key stakeholders and ensure efficient flow of information.
- Represent the JRO as and when required at internal and external meetings.
Bank Partners is an employment agency/employment business (as defined by the Conduct of Employment Agencies and Employment Businesses Regulations 2003) and is acting on behalf of its client in relation to this vacancy.