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.