Senior Clinical Trials Co-ordinator

2 weeks ago

Manchester, United Kingdom Greater Manchester Mental Health NHS Foundation Trust Full time

The Equality, Diversity, and Inclusion Research Unit (EDI-RU) is a collaboration between Greater Manchester Mental Health NHS Trust and The University of Manchester. EDI-RU is committed to undertaking research to tackle inequalities in mental healthcare, improve mental health outcomes for under-served populations, bridge the ‘research to practice gap. Our multi-faceted, inter-disciplinary distinctive co-production approach with service users, carers, and service providers as partners will enable our unique contribution to research and practice.

Our vision is to place the EDI-RU at the forefront of research, building capacity that better understands and harnesses people’s lived experiences to develop interventions, learning, and practice that help to achieve our strategic aims, ensuring commitment to integrated care policies and procedures.

An experienced Senior Clinical Trials Co-ordinator (SCTC) is required to support the work of GMMH’s Equality, Diversity & Inclusion Research Unit (EDI-RU). This involves but is not limited to day-to-day management of clinical trial activities and coordination of the trials across multiple sites.

The Senior Clinical Trials Coordinator is required to manage the research portfolio of both the Mental Health and Dementia specialities within EDI-RU unit which is an integral part of Research & Innovation (R&I), acting as professional lead for the programme of work.

To ensure that comprehensive, high quality and efficient administrative processes are in place for setting up studies, organising necessary approvals (ethics, HRA, local R&D, MHRA, research networks etc.), data management, ensuring full compliance with the UK Policy Framework for Health and Social Care Research; including financial management of study set-up costs and income recovery in conjunction with the R&I finance team.

The SCTC is expected to conduct literature reviews and searches to support and inform grant writing, and producing academic outputs - primarily papers, reports, and conference abstracts/presentations. The postholder will also have skills in mixed methods research (data collection, analysis, and dissemination) and knowledge and experience of research with groups currently under-represented in research. They will have a keen interest in involving patients, families and carers, members of the public, and other key stakeholders in research. Accordingly, the post requires excellent communication, interpersonal, and workload/task management skills. Opportunities to pursue professional development will be agreed with the line manager.

Greater Manchester Mental Health (GMMH) Foundation Trust employs over 6,400 members of staff, who deliver services from more than 160 locations.

We provide inpatient and community-based mental health care for people living in Bolton, the city of Manchester, Salford, Trafford and the borough of Wigan, and a wide range of specialist mental health and substance misuse services across Greater Manchester, the north west of England and beyond.

Greater Manchester is one of the world's most innovative, original and exciting places to live and work. From the beauty of the surrounding countryside to the heart of the vibrant inner city with great shopping, entertainment and dining options.

Wherever you go you will experience a great northern welcome with people famed for their warmth, humour and generosity.

Our people enjoy their work, have opportunities to learn and develop their skills and are encouraged to generate new ideas that improve care for our service users.

Study set-up

To act as a point of contact with study sponsor, Clinical Trials Units, Clinical Research Organisations, R&I and NIHR/ CRN Research Networks.

To liaise with and assist the study team regarding Research Ethics, HRA, and other regulatory submissions and funding arrangements.

To liaise with the line Manager, clinical trials team, and R&I finance team regarding feasibility and resource requirements of studies, after discussion with the lead investigator

To liaise with the R&I to gain Trust R&I approval

To liaise with NIHR LCRN for studies adopted to the portfolio.

For multi-centre studies, to lead on study initiation at the study sites according to regulatory requirements, including training staff in specific requirements.

For co-ordination of multi-centre studies, to travel to other centres and undertake study related duties as required

For multi-centre studies, to ensure, recruitment are at an acceptable level at each centre. Suggest and implement strategies for improving recruitment.

To be responsible for setting-up, maintaining and participating in effective and efficient communication processes with all stakeholders

To ensure Trial Steering Committees and Data Monitoring Committees are set up, and meetings organised as appropriate.

To draft and assist in the development of trial documents such as Schedules of Investigations, Patient Information Sheets, Informed Consent Forms, GP

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