Research Quality Assurance Officer

Job summary

Mid Yorkshire Teaching NHSTrust is delighted to offer a fantastic opportunity to join our dynamicResearch Management and Support team. You will join a specialised team withinthe dedicated R&D infrastructure at Pinderfields Hospital, liaisingclosely with a wide range of research investigators and their teams, servicesupport departments, external funders and local regulatory agencies.

The purpose of the role is toensure that research (including clinical trials of investigational medicinalproducts, medical devices or other interventions; and data/tissue basedclinical research studies) undertaken by Mid Yorkshire Teaching NHS Trust fulfilthe extensive legal requirements for management and delivery. The post-holderwill act as an expert for information and advice regarding research quality.With the Senior Research Manager, they will contribute to ensuring that, as faras possible, Mid Yorkshire Teaching Trust remains 'inspection ready' and worktowards positioning us as a leader in quality/compliance in clinical research.

The successful candidate willhave a keen interest in research, excellent communication, time management andorganisational skills and will enjoy working with a variety of keystakeholders.

Main duties of the job

The core focus of the role is tomanage and develop the trusts quality management system. This will include avariety of duties-

Manage and maintain oversight ofall trust research SOPs ensuring they are regularly reviewed for accuracy. Work with the senior research managersto ensure that MYTT is inspection ready. Ensure MYTT sponsored studiesare monitored according to local policy and that any training, support, andguidance is provided to the Chief Investigator and study team to ensure ongoingregulatory compliance. Lead on the monitoring/auditing of non commercialstudies within MYTT using a risk based approach and work with teams to agreeand action any resulting CAPA. Ensure that sponsored studiesunder go a proportionate risk assessment as part of their set up process andadvise on any design changes required to ensure quality of the research ismaintained whilst mitigating risks. Coordinate the design anddelivery of all training necessary to ensure high standards and regulatorycompliance across all staff groups working on the clinical research portfolio,this includes leading development of specific training according to demand. Lead on the design and implementationof process improvement projects that utilise our research management platform,EDGE.

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

Quality Systems

To manage the Trust quality control and assurance system which will include the review and updating of standard processes and related documentation and leading internal monitoring and audits of clinical trials activity across the organisation, reporting upon compliance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Good Clinical Practice Directive 92005/28/E. To work alongside the Research Leadership Team to deliver a quality framework to support, monitor and assure quality of Trust Sponsored research and hosted grants. The post holder will work closely with the Trust Research Delivery Team and Research Management Team to determine which SOPs and checklists are required, to lead on drafting the required documents, consulting on them, finalising, publishing and communicating them to a range of relevant audiences. The successful candidate will facilitate the management of research policies and standard operating procedures, ensuring that they are kept up to date, are documented and controlled, using appropriate document management software (SharePoint, EDGE). They will also organise training on the use of this system. The post-holder will work with Clinical Leads, Medical Teams, Nursing Teams, Management and Administrative staff within the Trust to ensure compliance with required quality standards. The post-holder will be required to work across the Trust and with external organisations to ensure that the services meet the required quality measures and will lead service improvement initiatives across the Research Team. To support the Senior Research Manager in ensuring that quality assurance activities are proportionate to the nature and scope of research activities performed by MYTT. Lead an internal programme of study monitoring in line with Trust SOP and work closely with Clinical Research Team. To create a monitoring programme to ensure that at least 10% of all hosted clinical trials at MYTT are monitored. Coordinate the planning, preparation, conduct and follow up of audits to monitor adherence to SOPs, protocols, contracts, the principles of GCP and relevant UK Regulations and provide written feedback of findings to Research Management Team and Research Committee. Perform system audits across the research infrastructure to ensure that they are efficient and effective, making recommendations for improvements and leading on process improvement projects. The post holder will work closely with the Research Management Team and Research Committee to ensure the implementation of quality systems across research studies. Analyse data collected from the audit and monitoring processes using appropriate software. Present monitoring and audit outcomes to research management team, Research Committee and other relevant audiences using PowerPoint presentation software and other tools as appropriate. Advise on actions required after monitoring to improve regulatory compliance and best practice standards. Ensure that vendors and systems are regularly audited and validated in line with inspection requirements. Determine, enforce and document database policies, procedures and standards. The post-holder will manage the local document database to ensure control of all documentation.

Performance Monitoring and Reporting

Lead on the development of the local portfolio management system Coordinate the production of regular research performance reports to internal and external audiences. Including but not limited to the Trust Research Committee, NIHR, DoH and MHRA. Manage the provision of research performance data so that it is reported in a timely manner to the Research Management Team, Research Committee and Trust Board. Keep an up to date record of research performance activity including recruitment data and lead on the reporting of Trust performance to internal and external audiences including Research Committee, NIHR, Y&H Research Network, DoH, MHRA. Work closely with the Research Management and Support team, Senior Clinical Trials Assistants and others to ensure all relevant metrics are recorded, and updated. Work with existing Trust databases, NIHR systems such as Open Data Platform Central Portfolio Management System and Local Portfolio Management System (Edge). Co-ordinate and Chair the Quality Group meeting and ensure that decisions, learning points and findings from the meeting are disseminated to the MYTT research community at every level in appropriate formats. Maintaining records and provide regular reports to the Research Director, Research Management team and Research Committee on regulatory compliance of research studies.

Clinical research planning and conduct

Support the review of research documentation for MYTT sponsorship approval, undertaking risk assessment and quality check of the research protocol and the associated documents according to the relevant SOPs. Ensure MYTT sponsored studies are monitored according to local policy and that any training, support, and guidance is provided to the Chief Investigator and study team to ensure ongoing regulatory compliance. Support the Research Governance Manager to oversee maintenance of a risk-based system for identifying and prioritising clinical research studies and trials requiring audit/monitoring. Support the Head of Research with the activities relating to preparation for statutory inspections (including MHRA, FDA and HTA). Support the Head of Research to respond to the findings of MHRA, FDA and HTA inspections, taking forward corrective action across the Trust. Identify and collate areas of risk and escalate findings and enable the Head of Research to report on corrective actions to the Quality Group and Research Committee Prepare presentations and meetings with all staff groups to inform of preparation activities and outcomes of inspections. Act as key contact with support services for inspection preparation activities. To ensure that data is archived and recorded in an appropriate manner in line with current research legislation and that this is continually monitored and adjusted as required. Collaborate on data innovation, giving suggestions and implementing new ways of using research data, linking with other departments, organisations and data sources.

Education and training

Keep abreast of new developments and/or requirements within clinical research and disseminate changes to clinical research delivery and management teams by way of presentations and/or group meetings. Support the research management team in increasing awareness of research across the Trust. Coordinate the design and delivery of all training necessary to ensure high standards and regulatory compliance across all staff groups working on the clinical research portfolio, this includes leading development of specific training according to demand. Develop training tools to enable the sharing of Good Clinical Practice. To design, develop, and co-ordinate training for research active trust staff on the use of research management systems such as Edge and ODP. Facilitating a process which ensures that all relevant staff are briefed on newly issued or revised policies and SOPs. Developing systems for communicating quality across the Directorate (intranet pages, Newsletters, team meetings, training sessions) and ensuring all relevant staff are aware of these. Ensure that necessary staff are trained in the use of the data management software. Be actively involved in training sessions for all staff to ensure that quality is embedded in the culture of the department. Ensure lessons learned from audits and monitoring are translated into changes in practice that are implemented across the complete research portfolio and research workforce.

Inaddition the post holders responsibilities will include the following :-

Archivingoversight Tosupport the Senior Research Manager in providing complex and highly specialisedadvice to researchers regarding research quality. Person Specification

Experience

Essential

Experience of working in a clinical research setting. Experience of MHRA inspections. Managing/Supervising staff. Experience of working to budgets. Change management/service improvements. Experience of working to targets. Experience of working with a busy/demanding environment. Experience in implementing HR & Departmental policies and maintaining associated records. Significant experience of risk management and mitigation. Significant experience of Quality Management Systems. Experience of process improvement and successful implementation of changes. Experience of handling conflict and resolution.

Desirable

Monitoring performance. Experience in taking an active lead in recruitment and retention of personnel within the organisation. Experience in conducting appraisals including objective setting. Experience in organising and chairing meetings. Experience monitoring Research studies. Experience of advising on research protocol design. Experience of providing training to colleagues.

Other

Essential

Adaptable and flexible according to the demands of the service. Understanding of need to maintain confidentiality.

Qualifications

Essential

Educated to Degree level or equivalent experience in the NHS/Healthcare environment with a sound educational background (4 GCSEs, grade C or above including Maths and English).

Desirable

Project Management qualification. Change Management qualification. Conflict resolution training. Post Graduate Qualification or equivalent.

Knowledge, Skills and Abilities

Essential

Awareness of own limitations. Excellent Microsoft Word/excel/email knowledge. Understanding of MHRA inspection requirements. Expert knowledge of Good Clinical Practice legislation. Proven administration and organisational skills. Excellent influencing and negotiating skills. Ability to analyse data and instigate resolution where required. Demonstrate good verbal and written communication skills with team/clients/relatives, using tact when required. Ability to manage/handle conflict. Good Time management skills. Ability to engage and motivate others. High level of initiative. Flexibility and able to adapt to change. Able to work as part of a team. Able to establish effective working relationships. Willingness to train others in Research processes and procedures. Ability to quickly learn and adapt to new computer software and databases.

Desirable

Knowledge of Clinical Governance and the NHS Plan. Knowledge of research legislation. Knowledge of data protection laws. Training/mentoring/coaching skills.

Personal Attributes

Essential

Effective and supportive team player. A professional, approachable manner. Confidence. Calm under pressure. Strong attention to detail and accuracy. Self motivated. Professional appearance. Professional image and positive approach to problem solving. Commitment to own personal and professional development and development of others within the team.

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