Research Governance Manager

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., 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.

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., 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 the 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.
Closing Dates: Please submit your application form as soon as possible to avoid disappointment; we reserve the right to close vacancies prior to the published closing date if we receive a sufficient number of completed application forms.
Communication: All communication related to your application will be via the email address you have provided. Please ensure you check your email account including your junk email regularly.
Easy read application: if you have a disability and find it difficult to complete our online application form, you can apply via our easy read application which you can find on the intranet https://www.nuh.nhs.uk/easy-read-job-application
NUH are now able to offer application completion support and interview preparation support. Please follow the link to book onto our sessions: Support for NUH Job Applications
If you are aged 16 or 17 and applying for a role that is more than 20 hours a week, please be aware that you will be asked to commence an Apprenticeship within the Trust alongside your role, as long as there is a suitable apprenticeship standard available. This is in line with the current guidance in England that whilst young people under the age of 18 can leave school (on the last Friday in June) they must then do one of the following:
+ Stay in full-time education, for example at a college
+ Start an Apprenticeship
+ Spend 20 hours of more a week working or volunteering, while in part-time education or training

Salary: The quoted salary will be on a pro rata basis for part time workers.
Disability Confidence: All applicants who have declared a disability and who meet the essential criteria for the post will be shortlisted.
At Risk of redundancy: NHS employees within the East Midlands who are 'at risk' of redundancy will be given a preferential interview where they meet the essential criteria of the person specification.
International Recruitment: If you are applying for a role with us from outside of the UK then please read the guidance on applying for a health or social care job in the UK from abroad.
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Consent:
+ Transfer of information: If I have previous NHS service - I consent to the transfer of my Electronic Staff Record (ESR) data between this and other NHS Trusts. I also consent to the Occupational Health Department confidentially accessing my occupational health records from my current or previous employer in order to check the status of my vaccinations, immunisations s and screening tests as relevant to the post. I understand this is an automated process and the information will only be used for these purposes prior to me taking up the position at NUH.
+ Disclosure and Barring Service: Your post maybe subject to a DBS check which incur a cost dependent on the level of check required (£42.90 for enhanced and £22.90 for standard). I agree to reimburse Nottingham University Hospitals NHS Trust the cost of a Disclosure and Barring Service (DBS) check if it is required (by deduction from first month's pay). Should I decide to withdraw from my job offer, I agree to reimburse Nottingham University Hospitals NHS Trust the cost of the DBS check undertaken by cheque or other agreed method.
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