Research Portfolio Manager (NHS AfC: Band 6) - North Staffordshire Combined Healthcare NHS Trust
North Staffordshire Combined Healthcare NHS Trust – Stoke-on-Trent, City of Stoke-on-Trent
Band 6, 15 hours per week, £37,338 - £44,962 pro rata per annum.
The Research Portfolio Manager will provide expertise in the overall set-up, governance, and management of all sponsored research.
You will review and advise on studies presented to feasibility for review and identify the need for service level agreements and any governance issues related to setting up the study. Once the studies are open, you will provide ongoing performance management to ensure that studies meet key performance indicators, whilst being compliant with UK research regulations.
The post holder will provide clinical research regulatory advice and guidance to clinicians and their teams, R&D staff, Chief Investigators and study teams. This will include facilitating researchers’ questions, and requests for information and ensuring that sponsors and study set-up progress. The post-holder will ensure that the R&D office collates the necessary approvals, data and documentation related to sponsored research.
The Trust is a leading provider of mental health, social care, learning disability and substance misuse services in the West Midlands. As a Trust, we remain bold and ambitious with plans for both service and system collaborative transformation over the coming years to improve the health and wellbeing of our local people through high quality care.
We pride ourselves on ensuring our team has their wellbeing put first and as such provide a range of wellness opportunities including flexible working. We are committed to the Greener NHS national ambition to becoming the world’s first ‘carbon net zero’ national health system by 2045. As part of this, sustainability is embedded in our strategy as one of our four key enablers. In order to deliver on this commitment, we recognise that we need a workforce that is as passionate as we are about achieving these goals, for the benefit of our service users, workforce, local communities and the planet alike.
The Trust is committed to ensuring that a diverse workforce is representative and inclusive at all levels.
The Job Description outlines the key duties/responsibilities, these include but are not limited to:
* Conduct feasibility assessments of new sponsored studies, provide and receive highly complex, sensitive and/or contentious research information, identifying risks and obstacles to the successful set up and delivery of each new study.
* Communicate with internal and external research stakeholders including pharmaceutical companies, clinical research network (CRN), senior clinical researchers, internal RFL support department staff and members of the R&D staff regarding setting up such research projects.
* Provide specialist UK and EU regulatory knowledge across a range of procedures, underpinned by regulatory knowledge (law), providing the knowledge of research regulations including ICH-GCP, Research Governance Framework that has been acquired through degree or equivalent experience or training around research and trial management.
* Advise researchers on the submission and application procedures to Research Ethics Committees (RECs), National Institute Health Research (NIHR) Portfolio, Confidentiality Advisory Group (CAG), Health Research Authority (HRA) and other research sites.
* Support the activities of the R&D Director and R&D Lead, deputising in their absence.
* Support R&D lead with documents and assessments or reporting to SIRO/Caldicott Guardian, in relation to research activities.
#J-18808-Ljbffr