Research Governance Manager inWakefield inWakefield PUBLISHED TUE 12 NOV 2024

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

• Manage study and organisation specific research support function processes.
• Support the Head of Research, Medical Director, and Research Director to deliver the Trust Research And Innovation Strategy.
• To monitor compliance to national and organisational standards in relation to research management and support and escalate non-compliance
• Ensure effective systems are in place to maintain Trustwide records of research activity, to confirm capacity and capability to conduct new research and to monitor research to provide quality assurance for research projects.
• Provide performance reports on the research activity.
• In conjunction with the Senior Research Manager, lead in the provision of expert advice and guidance to researchers and other colleagues aspiring to or participating in research activity
• Ensure an effective 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 fulfils its responsibilities under the UK Policy Framework for Health and Social Care Research.
• Support and maintain the research partnerships with other organisations including Universities, Charities, and other NHS Trusts.
• In conjunction with Research Finance Manager, establish and maintain appropriate research finance processes to ensure appropriate costing of research activities and reimbursement to and within the Trust.

About us

• Establish and maintain productive working relationships and optimal communication channels with:
• Staff working on research, development and service evaluation activity
• Staff working in corporate management functions and clinical support roles that interface with research activity such as Human Resources and Finance
• Principal and Chief Investigators leading research projects within the Trust, these roles may be held by staff employed outside the Trust e.g. academic institutions
• Yorkshire & Humber Research Delivery Network (RDN) and related groups and networks as appropriate

• Effectively communicate current and future NHS R&D national policies and procedures to all staff, ensuring their understanding of the implications of these on research conducted in the Trust.
• Promote research activity via a range of activities and events that encourage participation, spread learning and support good practice eg International Clinical Trials Day annual event.
• Provide expert support and well informed advice to researchers at all levels 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 portfolio specifically in community, commercial and trust sponsored studies.
• Liaise with partnership organisations, academic, commercial and other NHS organisations to ensure the trust infrastructure for research can support our portfolio of research.
• Contribute to contract negotiations to ensure appropriate funding is available to support studies.
• Ensure effective communication between all members of the research team
• Contribute to the setting up systems to maintain an overview and monitor progress including timelines, budgets and resources
• To project manage the progress of on-going research undertaken in the department.
• Maintain an accurate report of the progress of the research studies and provide departmental updates.
• To safeguard interest of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with ICH GCP guidelines.
• On behalf of the Research Director and In conjunction with the Senior Research Manager, ensure that all research projects carried out in the department are registered and reviewed by the Trust RM&S department and Health Research Authority prior to commencement and that updates and amendments are reported in a timely fashion.
• To drive and encourage the participation in original research carried out in the department.
• To work in partnership to develop further grant applications and contribute to the implementation of high quality research
• To provide advice and support to other members of the multidisciplinary team with regard to ICH GCP, R&D and REC registration and approval, project development, implementation, completion and dissemination.
• Liaison with pharmaceutical sponsors regarding feasibility and implementation aspects of proposed clinical trials.
• At all times to ensure clear, accurate records, developing data collection, case report forms and design of database where required.
• To establish and maintain a network of communication with other departments within the Trust, other relevant Trusts, non-commercial bodies and pharmaceutical sponsors.

Personal Education, Training and Development

• To keep up to date with departmental, Trust, NHS, and EU developments for the management of clinical research ensuring timely, effective implementation of changes.
• To attend courses as deemed relevant and to attend meetings and conferences as appropriate.
• Present posters or presentations at meetings and conferences as appropriate.
• Contribute to the planning and generation of publicity relating to the trials and the research team

Staff Management and Development

• Support the research management team in team and role development
• To act as a leader, resource and role model
• To take responsibility for the supervision and management of the research governance staff
• To be responsible for ensuring all members of the specialist team undergo regular and effective appraisal, and to support appropriate training and development opportunities in line with role requirements.
• To be responsible for ensuring the on-going recruitment of staff when necessary and ensure that job descriptions and staff contracts are reviewed on a regular basis.
• To be responsible for the co-ordination of annual leave and all other leave for RM&S
• To facilitate and maintain effective communication within the research team.
• Work in partnership with divisions and speciality leads to ensure performance management and trial targets are achieved.

Leadership

• Be an innovative, enthusiastic role model providing leadership, guidance and advice to staff on operational and professional issues promoting an open and honest and transparent culture.
• Provide leadership to the research management and support team and working with the Senior Research Manager, develop new roles / ways of working (High Impact Changes) linked to the research strategy and national metrics.
• Lead on developing procedures and processes to maximise team effectiveness.
• The post holder will be responsible for recruitment to posts that they line manage and for undertaking disciplinary or grievance procedures for those posts.

Management / Operational

• The post holder will carry operational responsibility for the research governance function
• Decision making about highly complex and specialist research information is an important part of this role and will be supported by the Senior Research Manager and relevant managers within the corporate directorates
• The post holder must be competent and confident to make sound judgements and decisions regarding areas of responsibility
• The post holder must be available to provide advice, guidance and direction during office hours on the issues relating to research support and management
• Ability to analyse and interpret national and international research policy to ensure that any research being led and sponsored by the Trust complies with all relevant regulations.
• Employ effective decision-making skills to address complex issues and use effective change management skills to implement these.
• Take the lead in investigation of incidents / complaints when required, including detailed reports / letters to complainants.
• Identify and develop proposals and business cases as required for future service innovation.
• With team members undertake performance development reviews including reviewing the performance measures framework.
• Monitor sickness, absence and competence issues in line with Trust Policy.

Advocate

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

Governance / Quality

• On behalf of the research committee and in conjunction with the Senior Research Manager the post holder will develop and maintain policies and standard operating procedures for the trust research department and collaborations with external organisations.
• As the Trust RM&S procedures will impact on staff and all researchers Trustwide (including those researchers outside the research function) the job holder will implement and explain the impact of these changes to staff Trustwide.
• Proposes policy changes to NHS research and development by contributing to national consultations and working groups.
• Work with the National Institute for Health Research (NIHR), the Research Delivery Network and other organisations and individuals to understand local, regional and national policies relevant to NHS R&D and to effectively communicate these within the Trust.
• Responsible for collating and entering appropriate data relating to activities within appropriate information systems and EDGE

Education / Training

• Takes responsibility for own continuing professional development and performance, including identifying own development needs
• Participates in the supervision and the teaching of new staff members.
• Identifies training needs and develop training resources for RM&S staff to enable role development and to meet the needs of the service.
• Has delegated responsibility from the HR department to operate the Research Passport Scheme to issue (in line with HRA approval conditions) Honorary Research Contracts or Letters of Access for research staff not employed by the Trust.
• Deliver research training and guidance to individuals and groups both internal and external to the trust.

Resources and Finance

• Critically examine working practices within the department to identify cost improvements and effective measures, develop and implement action plans.
• Contribute to generating commercial activity and negotiating income distribution relating to research trials in accordance with policies and procedures
• On behalf of the research committee and in collaboration with the Senior Research Manager negotiate with research study sponsors or sponsor representatives regarding study costing using appropriate guidance e.g. AcoRD and agree financial terms on research study contracts.
• Undertake thorough reviews of research protocols, to analyse and make definite judgements on the activity and resource requirements based on information which will be highly complex.
• Liaise with researchers, senior managers and service support coordinators to discuss cost and operational implications.
• Have an in depth understanding of the NIHR income distribution policy and be able to action this within the trust setting.
• Ensure appropriate quality assurance and sense check is conducted prior to research agreement execution.
• Provide experienced knowledge in NHS costing and contracting research issues and processes.
• Lead, in conjunction with the Senior Research Finance Manager, on the tracking and reclaiming of excess treatment costs on behalf of the trust.
• In conjunction with the Senior Research Finance Manager ensure all that all research income owed to RM&S and the wider research team has been reclaimed in a timely manner.