Development of a core competency framework for clinical research staff

Merrie Gowie*, Danielle Wilson, Sarah Gregory, Louise L. Clark

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
257 Downloads (Pure)



To develop a pilot core competency framework for clinical research staff.


Clinical research networks in the United Kingdom (UK) are continuously developing as study demands change, thereby creating more diverse opportunities for individuals working in clinical research roles. It is imperative for clinical research staff to be skilled and competent to enable consistent delivery of high quality research studies and to provide the best care for participants, irrespective of their professional background.


A multi-method design was adopted which included three phases; Phase One – a conceptual review of current competency frameworks in the literature; Phase Two - a focus session with clinical researchers and thematic analysis to elicit suggestions and perspectives of core competencies; and Phase Three - development and refinement of a pilot competency tool.


Common indicators identified in the literature review were incorporated into the pilot competency framework. Three main overarching themes emerged from the thematic analysis of the focus session data; Theme One – clinical research attributes; Theme Two – career definition and development and; Theme Three – competency toolkit.


Current frameworks are comprehensive when applied to the research nurse role, however typically do not consider the competencies and development of non-registered staff. The present study also identified a gap in the consideration of soft skills as a core competency. Future work may include an additional phase to field test the pilot framework, seek feedback for further refinement and to include an assessment template.


The establishment of a standardised competency framework for clinical research staff, irrespective of professional background, provides a valuable guide for individual researchers and their organisations. It adds to the evidence of the move towards professional registration for those working in clinical research and fosters motivation to develop and progress in the field.

Original languageEnglish
Article number100301
JournalJournal of Interprofessional Education and Practice
Early online date9 Dec 2019
Publication statusPublished - 1 Mar 2020


  • Career
  • Clinical research
  • Competency
  • Continuing professional development
  • Framework
  • Researcher


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