Research Governance Manager

at  Nottingham University Hospitals NHS Trust

Please see extended Job Overview in the Job Description and Personal Specifications for this post for more Details:
The Research Governance Manager will oversee the research governance of all sponsored and lead site research trials from set up to close-out, overseeing sponsorship review and confirmation of capacity and capability. They will assist in maintaining systems to assure the quality of clinical research undertaken within NUH in accordance with the prevailing legislative and best practice requirements, including the UK Policy Framework for Health and Social Care for Research, Good Clinical practice, the Medicines for Human Use (Clinical Trials) Regulations, the Human Tissue Act and the Mental Capacity Act. They will also provide specialised expert governance advice and guidance for researchers and research support staff at all stages of the research lifecycle from project design, ethical and Health Research Authority (HRA) application/approval processes and contract arrangements, through to study set up, patient recruitment, study close out and archiving.
Please see extended duties in the Job Description and Personal Specifications for this post for more Details:
The post holder, based at QMC (and working across all three sites), will be responsible for promoting and developing a culture that supports high quality research through help and support to research leaders and their teams with a focus on NUH sponsored studies.
The post holder will play a key role in the co-ordination of standards, working practices and policy implementation to ensure that NUH and our partners are at all times compliant with both internal policies and external regulatory frameworks.
With over 19,000 staff, we are one of the biggest employers in the city with a central role in supporting the health and wellbeing of our local population. We play a leading role in research, education and innovation.
Come and join our wonderful team at NUH. We are big believers in diversity and welcome new ideas to help develop our team in order to deliver world class healthcare to the vast patient populations we serve. With endless personal development opportunities available, at NUH we will endeavour to turn your job into a career!

We particularly welcome applications from people who identify as Black, Asian and Minority Ethnic, or Disabled, as we are striving to be better represented at NUH.

• Research Governance & Risk Management
• To initiate and develop robust systems, proportionate risk assessment and governance approval processes for the management of research
• To use appropriate systems, policies and procedures to ensure that all research at NUH complies with the UK Policy Framework for Health and Social Care Research, Good Clinical Practice and all other regulatory requirements.
• To develop and maintain specialist knowledge on all research governance regulatory requirements.
• To lead on the development of new policies and procedures for research governance processes, including but not limited to the development and update of Standard Operating Procedures (SOPs) as required.
• Where poor practice is highlighted or governance standards are not met, to instigate and lead on improvement plans
• Support the quality team in their role of quality oversight of research at NUH.
• To support preparation and implement action plans for inspections and reviews by regulatory bodies including but not limited to the MHRA
• To support implementation of any recommended requirements from statutory inspections.
• To ensure that the Trust has robust systems in place to monitor serious adverse events and non-compliances. To support with review and advice as required.
• To ensure that robust systems are in place to identify, record and store information on all Trust research activity (from study start up to completion) and that the quality of that information is monitored and maintained and is sufficient to meet all national research reporting requirements.
• Ensure researchers working on NUH led research, internal and external, comply with relevant Trust policies and procedures and take remedial action where appropriate.
• Work closely with the Finance Department to develop efficient systems for costing all proposed non-commercial Trust-led research. Aim to ensure that all research sponsored by the Trust is subject to full cost recovery.
• Management and development
• To lead and motivate a team of Senior Research Governance Facilitators and Research Administrators.
• To be directly accountable for all the above staff with responsibility for recruitment, mentoring, training, setting of objectives, and annual appraisal reviews.
• To provide leadership in developing and maintaining a culture of continuous improvement within the team and a service end user focussed approach.
• To adhere to all Trust Human Resources Management policies and procedures, ensuring compliance with employment legislation and regulation at all times.
• To deputise for the Head of Research Governance, Quality and Integrity at times, including at external meetings

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• Communication and working relationships
• Effective Trust wide communication, promotion and dissemination of research governance and quality issues including new guidance and best practice.
• Advise and support highly complex and sensitive issues relating to the management of specialist areas of research
• To develop excellent relationships with research active clinicians and research delivery staff ensuring effective communication of standards required for conducting research including quality performance indicators
• Co-ordinate communication between multiple departments and services during the set up for new studies to facilitate timely and effective study start up.
• Maintain excellent relationships and regular communication with all research support staff and service department managers. Facilitate/encourage open discussion and shared awareness/learning of operational research issues/challenges.
• Lead on resolving service support/capability issues identified during protocol development/sponsorship review to facilitate timely resolution. Escalate issues to the Head of Research Governance, Quality and Integrity as required.
• Contribute to promotion of research successes – internal and externally.
• To deputise where necessary for the Head of Research Governance, Quality and Integrity on matters of research governance, internal and external to Trust.
• Where identified as needed, provide specialised and targeted training and support for clinical research teams or research delivery teams.

Support and contribute to relevant local and national meetings

Please refer the Job description for details