Developing the role of Clinical Research Practitioners in the NHS: Fostering professionalism in a new occupation Fiona O’Neill Fiona.h.oneill@nihr.ac.uk NIHR Clinical Research Network

The UK research landscape Exciting environment Expanding research environment Primary, secondary, end of life care as well as community setting

The UK research landscape Political commitment to supporting life-sciences industry Health & Social Care Act 2012 / NHS Constitution 2013 Embed clinical research in all aspects of care

The NIHR The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. The NIHR plays a key role in the Government’s strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. The NIHR is the research arm of the NHS.

Our workforce We are a funder (10,000 within the CRN) Work as part of multidisciplinary teams to deliver research across all patient pathways and specialties Becoming more diverse Work within a highly regulated environment (high potential risk low harm) Occupy roles that are valued and provide worthwhile opportunities for graduates as well as clinicians Largely hidden and not very well understood Connected to but not the same as the clinical academic workforce

Exciting environment Expanding research environment Primary, secondary, end of life care as well as community setting

Roles within Clinical Research Delivery Exciting environment Expanding research environment Primary, secondary, end of life care as well as community setting

Clinical Research Practitioners Pragmatic response not planned Provides valued roles for graduates & others without a clinical qualification Varied responses to induction and continuing development Career pathways undefined and undeveloped No consensus re boundaries Focus on skill management-skill development & flexibility Realistic and informed view of future workforce Learning from others

Developing an Integrated Workforce Framework 7 Elements within Clinical Research Ethics, Patient Safety and Clinical Governance Research Development and Regulation Clinical Studies Operations Science and Research Design Study and Site Management Data Management and Informatics Communication and Relationships Exciting environment Expanding research environment Primary, secondary, end of life care as well as community setting 4 Levels applied to each Element Advanced Fundamental knowledge of principles and contexts Intermediate Core Awareness

Integrated Workforce Framework Foundation-change the conversation Consistent description of the workforce Emphasis on the organisational context-positive practice environments Engagement and evaluation is key

Next steps Identity and community Voices and stories of their practice Leadership Engagement Assurance and Trust Risk assessment Continuum of assurance Developing standards-training and education Learning from others is key.......