Research Governance Manager

Job summary

We are excited to offer the opportunity to join our dynamic and vibrant Research Management and Support team at Mid Yorkshire Teaching NHS Trust. Thisresearch governance role is pivotal in providing assurance that research withinthe Trust meets or exceeds national and local standards and that research ispromoted and supported to afford service users the opportunity to participatein innovative services. The purpose of the role is to ensure that clinical research (includingclinical trials of investigational medicinal products, medical devices or otherinterventions; and data/tissue based clinical research studies) undertaken by MidYorkshire Teaching Trust fulfil the extensive legal requirements for managementand delivery.

Main duties of the job

Manage study and organisation specific researchsupport function processes. Support the Head of Research, Medical Director, andResearch Director to deliver the Trust Research And Innovation Strategy. To monitor compliance to national andorganisational standards in relation to research management and support andescalate non-compliance Ensure effective systems are in place tomaintain Trustwide records of research activity, toconfirm capacity and capability to conduct new research and to monitor researchto provide quality assurance for research projects. Provide performance reports on the research activity. In conjunction with the Senior Research Manager, leadin the provision of expert advice and guidance to researchers and othercolleagues aspiring to or participating in research activity Ensure aneffective and smooth process for confirmation of capacity and capability for research project initiation In conjunction with the Senior Research Manager,establish and maintain appropriate Sponsor processes to ensure the Trust fulfilsits responsibilities under the UK Policy Framework for Health and Social CareResearch. Support and maintain the research partnerships withother organisations including Universities, Charities, and other NHS Trusts. In conjunction with Research Finance Manager,establish and maintain appropriate research finance processes to ensureappropriate costing of research activities and reimbursement to and within theTrust.

About us

We provide care and support to over a million people inWakefield and Kirklees in their homes, community settings and across ourthree hospital sites at Pontefract, Dewsbury and Pinderfields (Wakefield).

Always striving for excellence, we are at the forefront ofinnovation and research, and we invest in teaching and the development of ourworkforce.

We live by our values of caring, improving, being respectfuland maintaining high standards. We listen and learn because we aim to make MidYorkshire the best place to work and receive care.

We value diversity and welcome talent and enthusiasmirrespective of age, disability, neurodivergence, sex, gender identity andgender expression, race or ethnicity, religion or belief, sexual orientation,or other personal circumstances including providing unpaid carers support tosomeone with a health and care need. As ethnic minority groups, members of theLGBTQ+ community, and people with a disability/neurodivergence are currentlyunder-represented across the organisation, we encourage applications frommembers of these groups. We have policies and procedures to ensure allapplicants are treated fairly and consistently.

We are proud of our staff networks - who offer valuableguidance and feedback from those with lived experience.

We have a clear vision and you could be part of this Ifyou share our values and you want to make a difference to the lives of ourpatients and their families and carers, we would love to hear from you.

Job description

Job responsibilities

Establishand maintain productive working relationships and optimal communicationchannels with: Staffworking on research, development and service evaluation activity Staffworking in corporate management functions and clinical support roles thatinterface with research activity such as Human Resources and Finance Principaland Chief Investigators leading research projects within the Trust, these rolesmay be held by staff employed outside the Trust academic institutions Yorkshire& Humber Research Delivery Network (RDN) and related groups and networks asappropriate Effectively communicate current and future NHS R&D national policiesand procedures to all staff, ensuring their understanding of the implicationsof these on research conducted in the Trust. Promote research activity via a range of activities and events thatencourage participation, spread learning and support good practice egInternational Clinical Trials Day annual event. Provide expert support and well informed advice to researchers at alllevels in the organisation on matters relating to research proposal design,approval and ongoing governance. Represent the Trust at regional and national conferences and meetings. Contribute to the development of the Trust research portfoliospecifically in community, commercial and trust sponsored studies. Liaise with partnership organisations, academic, commercial and otherNHS organisations to ensure the trust infrastructure for research can supportour portfolio of research. Contribute to contract negotiations to ensure appropriate funding isavailable to support studies. Ensure effective communication between all members of the research team Contribute to the setting up systems to maintain an overview and monitorprogress including timelines, budgets and resources To project manage the progress of on-going researchundertaken in the department. Maintain an accurate report of the progress of the research studies andprovide departmental updates. To safeguard interest of patients by liaison with relevant trialpersonnel and contribution to trial design and protocol and ensure compliancewith ICH GCP guidelines. On behalf of the Research Director and In conjunction with the SeniorResearch Manager, ensure that all research projects carried out in thedepartment are registered and reviewed by the Trust RM&S department and HealthResearch Authority prior to commencement and that updates and amendments arereported in a timely fashion. To drive and encourage the participation in original research carriedout in the department. To work in partnership to develop further grant applications andcontribute to the implementation of high quality research To provide advice and support to other members of the multidisciplinaryteam with regard to ICH GCP, R&D and REC registration and approval, projectdevelopment, implementation, completion and dissemination. Liaison with pharmaceutical sponsors regarding feasibility andimplementation aspects of proposed clinical trials. At all times to ensure clear, accurate records, developing datacollection, case report forms and design of database where required. To establish and maintain a network ofcommunication with other departments within the Trust, other relevant Trusts, non-commercial bodies and pharmaceutical sponsors.

Personal Education, Training andDevelopment

To keep up to date withdepartmental, Trust, NHS, and EU developments for the management of clinicalresearch ensuring timely, effective implementation of changes. To attend courses asdeemed relevant and to attend meetings and conferences as appropriate. Present posters or presentations at meetings andconferences as appropriate. Contribute to theplanning and generation of publicity relating to the trials and the researchteam

Staff Management and Development

Support the research management team in team androle development To act as a leader, resource and role model To take responsibility for the supervision andmanagement of the research governance staff To be responsible for ensuring all members of thespecialist team undergo regular and effective appraisal, and to supportappropriate training and development opportunities in line with rolerequirements. To be responsible for ensuring the on-goingrecruitment of staff when necessary and ensure that job descriptions and staffcontracts are reviewed on a regular basis. To be responsible for the co-ordination of annualleave and all other leave for RM&S To facilitate and maintain effective communicationwithin the research team. Workin partnership with divisions and speciality leads to ensure performancemanagement and trial targets are achieved.

Leadership

Be an innovative,enthusiastic role model providing leadership, guidance and advice to staff onoperational and professional issues promoting an open and honest andtransparent culture. Provide leadership to theresearch management and support team and working with the Senior ResearchManager, develop new roles / ways of working (High Impact Changes) linked to theresearch strategy and national metrics. Lead on developingprocedures and processes to maximise team effectiveness. The post holder will be responsible for recruitment to posts that theyline manage and for undertaking disciplinary or grievance procedures for thoseposts.

Management / Operational

The post holder willcarry operational responsibility for the research governance function Decision making abouthighly complex and specialist research information is an important part of thisrole and will be supported by the Senior Research Manager and relevant managerswithin the corporate directorates The post holder must becompetent and confident to make sound judgements and decisions regarding areasof responsibility The post holder must beavailable to provide advice, guidance and direction during office hours on theissues relating to research support and management Ability to analyse andinterpret national and international research policy to ensure that anyresearch being led and sponsored by the Trust complies with all relevantregulations. Employ effective decision-makingskills to address complex issues and use effective change management skills toimplement these. Take the lead ininvestigation of incidents / complaints when required, including detailedreports / letters to complainants. Identify and developproposals and business cases as required for future service innovation. With team membersundertake performance development reviews including reviewing the performancemeasures framework. Monitor sickness, absenceand competence issues in line with Trust Policy.

Advocate

Recognise, prevent anddiffuse potential areas of conflict and take a key role in the management ofthe outcome.

Governance / Quality

On behalf of the researchcommittee and in conjunction with the Senior Research Manager the post holderwill develop and maintain policies and standard operating procedures for thetrust research department and collaborations with external organisations. As the Trust RM&S procedures will impact onstaff and all researchers Trustwide (including those researchers outside the researchfunction) the job holder will implement and explain the impact of these changesto staff Trustwide. Proposes policy changes to NHS research anddevelopment by contributing to national consultations and workinggroups. Work with the National Institute for Health Research(NIHR), the Research Delivery Network and other organisations and individualsto understand local, regional and national policies relevant to NHS R&D andto effectively communicate these within the Trust. Responsible for collating and entering appropriate data relating toactivities within appropriate information systems and EDGE

Education / Training

Takes responsibility forown continuing professional development and performance, including identifyingown development needs Participates in thesupervision and the teaching of new staff members. Identifies training needsand develop training resources for RM&S staff to enable role developmentand to meet the needs of the service. Hasdelegated responsibility from the HR department to operate the ResearchPassport Scheme to issue (in line with HRA approval conditions) HonoraryResearch Contracts or Letters of Access for research staff not employed by theTrust. Deliver research trainingand guidance to individuals and groups both internal and external to the trust.

Resourcesand Finance

Critically examineworking practices within the department to identify cost improvements andeffective measures, develop and implement action plans. Contribute to generating commercial activity and negotiatingincome distribution relating to research trials in accordance with policies andprocedures On behalf of the researchcommittee and in collaboration with the Senior Research Manager negotiate withresearch study sponsors or sponsor representatives regarding study costingusing appropriate guidance AcoRD and agree financial terms on researchstudy contracts. Undertake thorough reviews of research protocols, to analyse and makedefinite judgements on the activity and resource requirements based oninformation which will be highly complex. Liaise with researchers, senior managers and service supportcoordinators to discuss cost and operational implications. Have an in depthunderstanding of the NIHR income distribution policy and be able to action thiswithin the trust setting. Ensure appropriate quality assurance and sense check is conducted priorto research agreement execution. Provide experienced knowledge in NHScosting and contracting research issues and processes. Lead, in conjunction withthe Senior Research Finance Manager, on the tracking and reclaiming of excesstreatment costs on behalf of the trust. In conjunction withthe Senior Research Finance Manager ensure all that all research income owed toRM&S and the wider research team has been reclaimed in a timely manner. Person Specification

Experience

Essential

Extensive experience of working autonomously within R&D at an advanced level. Extensive experience of NHS R&D facilitation. Evidence of continued professional development. Proven experience of management/ leadership skills and line managing staff. Experience of developing and implementing policies and standard operating procedures.

Desirable

Experience with research grant application process. Practical Project Management experience. Up to date experience of AcoRD in NHS setting. Experience of negotiating commercial research contracts and budgets. Experience of using Edge.

Qualifications

Essential

Professional knowledge acquired at degree level supplemented by specialist training, experience and short courses to Masters level or equivalent training or significant experience in NHS research management. GCP certification.

Desirable

Research qualification. Management qualification.

Knowledge and Awareness

Essential

In depth specialist knowledge of research support processes involved with managing NHS research. In depth knowledge of legislation relevant to healthcare research. In depth knowledge of regulatory requirements for NHS research. Knowledge of different commercial research activity. Knowledge of sponsorship processes within the NHS.

Desirable

Experience with research grant application process. Practical Project Management experience. Up to date experience of AcoRD in NHS setting. Experience of negotiating commercial research contracts and budgets.

Skills and Abilities

Essential

Ability to negotiate with commercial and non commercial partners Organisation and negotiation skills. Excellent verbal, written, interpersonal and communication skills. Leadership & high degree of motivation skills. Computer literate with standard keyboard skills and ability to produce high level reports. Ability to motivate self and others. Ability to translate national policy or guidance for application to the local situation. Able to use sound judgement and reasoning in decision making, and problem prioritisation.

Desirable

Evidence of leading and facilitating change. Teaching / assessment skills.

Personal Attributes

Essential

Diplomatic. Assertive and confident. Personal and professional maturity. Recognition of own limitations. Ability to work both on own initiative and within a team. Flexible and positive approach to work. Ability to adapt to changes in national and international regulations and policies. Proven ability to organise own work in busy environment and with time-critical targets. Adaptable and flexible according to the demands of the service.

Desirable

Driving Licence / Able and willing to travel regionally and nationally.

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