The Research and Development department at NNUH is growing and we are seeking an enthusiastic, organised and goal-orientated individual to join our supportive and dynamic team to help us develop our service.
As Research Governance Coordinator you will be responsible for assuring compliance of our sponsored research with all relevant laws and regulations and will deliver on-going research audit and monitoring programs.
Our ideal candidate will have significant experience of working in a research support environment with an understanding of NHS R&D systems and clinical research issues such as research governance, ethical review, Medicines for Human Use Regulations, etc.
Do you have significant experience of clinical research governance, audit, or monitoring systems together with line management experience? If you do, we would be delighted to hear from you.
The Research Governance Coordinator is responsible for the successful preparation, review, update and maintenance of the Trust's Quality Management System and associated processes for research governance. This will include oversight and management of research sponsored by NNUH.
To ensure that systems and processes are efficient, effective, proportionate, and assure regulatory compliance of our research, you will liaise with other senior colleagues involved in research at NNUH. In recognition of the growing proportion of research studies that involve both the Trust and the University of East Anglia the post-holder will also work closely with colleagues in UEA Research and Innovation Office, Norwich Clinical Trials Unit and Quadram Institute Bioscience to ensure alignment of processes to support joint working.
You will assist the Research Services Manager in the development and refinement of the research governance administrative procedures throughout the Trust, working in collaboration with the NIHR networks and using national and regional information systems to support approval and delivery of research within the Trust.
You will deliver on-going research audit and monitoring programmes ensuring compliance with Trust SOPs and research policies.
You will line manage the Research Governance Administrator, Clinical Trial Monitor, and the Research Data Administrator, supervising their activities, overseeing their training and development, and managing their performance.
About us
- In discussion with colleagues to identify and develop improvements to systems related to research governance and management.
- To maintain the Joint Research Governance Policy and Standard Operating Procedures agreed between the Trust and the University, ensuring they are reviewed as per the schedule, kept up to date and available on the website.
- To maintain an up-to-date knowledge of legal and regulatory requirements pertaining to research as well as the processes, procedures and requirements of the relevant regulatory bodies eg MHRA, HRA etc in order to correctly advise researchers and colleagues and ensure our SOPs, policies and procedures comply with requirements.
- To attend meetings and advise members of the Joint Research Governance Committee on matters such as Trust policies transfer and retention of tissue, and all relevant legislation.
- Working with the University Contracts Manager and NNUH Senior Contracts Specialist, to develop and maintain template Sponsor agreements which minimise the risk to the Trust and can be used by Research Study Officers as appropriate where the Trust acts as Sponsor.
- To be the Trusts named archivist in the discharge of the Trusts responsibilities under the Medicines for Human Use (Clinical Trials) Regulations for CTIMPs and Medical Device trials.
- To co-ordinate and supervise the day-to-day activities of the Research Governance Administrator, Clinical Trial Monitor and Research Data Administrator, ensuring that the research governance function is supported, that the R&D database (EDGE) is complete, kept accurate, up to date and maintained and that management information and other reports are produced as required.
- To lead the preparations and conduct for any regulatory inspection or audit of the Trusts research.
- To refer any major concerns on research governance and sponsorship issues to the Research Services Manager or Director of Research Operations.
- To be responsible for Deputising in the absence of the Research Services manager for signing Capacity and Capability letters for Research studies.
Please refer to the Job Description for the full specification of responsibilities and requirements for this post.
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