Clinical Research Governance Manager - UOD2005
| Dyddiad hysbysebu: | 30 Medi 2025 |
|---|---|
| Cyflog: | £37,174 i £45,413 bob blwyddyn |
| Oriau: | Llawn Amser |
| Dyddiad cau: | 07 Hydref 2025 |
| Lleoliad: | Dundee, Dundee, DD1 4HJ |
| Cwmni: | University of Dundee |
| Math o swydd: | Parhaol |
| Cyfeirnod swydd: | 5713_1759247839 |
Crynodeb
The Clinical Research Governance Manager is based in the Sponsor Office, Tayside Medical Science Centre (TASC), Ninewells Hospital, Dundee.
TASC was established in 2010 to combine the established research strengths of the University of Dundee, (UoD) and NHS Tayside, (NHST) and to catalyse the design and delivery of Clinical Research in a safe and effective manner. TASC is a core part of the NHS Research Scotland, (NRS) and its clinical research infrastructure.
NRS supports clinical research through partnership working between the Chief Scientist Office (CSO) of the Scottish Government Health Directorate and Scottish Health Boards. NRS works with Scottish Universities and other organisations to ensure that Scotland provides a highly supportive environment for clinical research.
A key role of TASC is to lead NRS activity in the East node and to provide the structures and governance that will facilitate clinical research for all health and social care Professionals. TASC also aims to promote a strong culture of high-quality research within the wider NHS and academic communities.
TASC's role is to facilitate trusted, high quality and innovative clinical research to improve the health outcomes of the people of Tayside and beyond. This mission is guided by 4 key values:
* Quality: we aim for excellence in all that we do
* Integrity: having a culture of transparency, trust and accountability
* Valuing People: treat everyone with dignity and respecting diversity
* Working together: working and communicating openly and as one team
Our strategy follows the themes outlined on the 4 nations report on the Future of Clinical Research Delivery, namely 'Saving and Improving Lives' (https://www.gov.uk/government/publications/the-future-of-uk-clinicalresearch-delivery/saving-and-improving-lives-the-future-of-uk-clinical-research-delivery) .
Our aim is to tailor these to reflect local strengths and capabilities and to ensure that we play an integral role in the development of Scotland as a preferred location for health and social care research.
* Clinical research delivery embedded in NHS
* Patient-centred research * Streamlined, efficient and innovative clinical research
* Research delivery enabled by data & digital tools
* A sustainable & supported research delivery workforce Tayside is a centre of excellence for medical research.
This is facilitated through the availability of joint NHS Tayside and University of Dundee world class research facilities such as the Clinical Research Centre and Clinical Research Imaging Facility. Funding for research is provided from the Chief Scientist Office, grant income and cost-recovery from commercial research income.
The Research Governance team are based within the Sponsor Office and risk assess all non-commercial clinical research for Sponsorship on behalf of NHS-Tayside and University of Dundee and are responsible for Sponsor oversight throughout the life cycle of the project.
The post holder will be based at Ninewells Hospital and Medical School, one of Europe's largest teaching hospitals where the School of Medicine provides outstanding opportunities in medical education and training supported by world class research facilities.
Role Purpose
The Research Governance Manager will be responsible for ensuring the continued high-quality conduct of clinical research Sponsored by the University of Dundee (UoD) and NHS Tayside (NHS T) by carrying out documented risk assessments and managing research governance activities to ensure legislative compliance and data and research integrity.
Working under the direction of the Senior Clinical Research Governance Manager, the postholder will be expected to ensure that all research sponsored by the UoD/NHST complies with the UK Policy Framework for Health & Social Care Research, ICH GCP standards and best practice, including MHRA guidance and study Sponsor requirements. In addition, they will be expected to
: * Support the development of new, and evolve existing, research Standard Operating Procedures
* Ensure that research active staff are provided with professional advice and support in designing and delivering clinical research and are monitored according to research governance & quality assurance requirements
* Support the training of research staff, co-ordinate and advise on research governance activities
* Ensure confidential research documentation are collated, recorded, and filed according to appropriate policies and standards.
* Work collaboratively with other research colleagues locally and nationally when required
* Undertake varying duties to ensure governance and oversight of clinical research within Tayside
Key Responsibilities
* Risk assessment of non-commercial research for Sponsorship by the UoD/NHST.
* Oversight to ensure all necessary regulatory documents and research approvals are obtained for studies sponsored by the UoD/NHST
* Management of breaches of GCP in sponsored research studies
* Development and maintenance of research-specific Sponsorship documentation
* Liaison with Investigators, Supervisors, Students, REC Committees, Patient and Public Involvement groups, NHS R&D, Information Governance and other regulatory bodies as required.
* Manage and oversee the assessment and implementation of research protocol amendments
* Ensure all amendments are communicated effectively to relevant stakeholders.
* Maintain accurate trial documentation.
* Monitor researchers' compliance with amended protocols
. * Conduct training sessions for clinical researchers, student supervisors and students.
* Prepare for and attend regular audits and inspections to ensure compliance with regulatory requirements
* Review Organisational Information Documents, Data Protection Impact assessments and ensure appropriate Legal Agreements are put in place for each project
* Address and resolve any governance-related issues that arise during the lifetime of research projects sponsored by UoD/NHST
* Stay up to date with changes in regulatory requirements and industry best practices.
* Supervision and support of junior staff