Background: Clinical research nursing is an emerging specialty practice. Clinical research nurses (CRNs) work to make protocol-related care safe for the research subjects while simultaneously maintaining protocol fidelity. They must continuously balance the needs of the research subjects and the study requirements. Purpose: The purpose of this qualitative study was to describe CRNs’ perceptions of the value of their role. Methods: Two focus groups were conducted with a purposive sample of 18 CRNs. An interview guide consisting of eight open-ended items was used. Data analysis used critical elements from Krueger's systematic steps for analyzing focus group data. Results: Five major themes emerged from 168 coded statements contained within the focus group transcripts: comprehensive nursing care of research subjects, training and education of research subjects and staff, contributions to clinical science, unique combination of clinical and critical thinking skills, and CRN practice attributes. Subcategories were also identified. In general, participants felt strongly about the value they added. Clinical research nursing requires the use of a variety of abilities and skills, including critical thinking and problem solving, as well as clinical and research knowledge. The CRNs in this study described incorporating these and other elements into their practice, which they associated with their specialized role. The five themes that emerged help elucidate the importance and utility of including CRNs on research teams. Conclusions: The unique combination of applied research knowledge and expert clinical skills sets the specialty of clinical research nursing apart. The study findings, in particular the five themes, provide an evidence-based framework that will be useful in the development of competencies for CRN specialty practice. In helping to bring research findings to bear on clinical care, the impact of CRNs’ practice extends beyond the individual patient to larger patient populations.

Background The role of Clinical Research Nurses across the globe has not been evaluated to identify similarities or differences among specific activities. Aims This study’s aims were to determine differences in Clinical Research Nurses most frequently performed activities, if these activities are reflective of those previously described in the literature, and job titles Clinical Research Nurses use to self-identify. Methods An online cross-sectional survey distributed via snowball sampling through email, social media, and research nurses’ networks included questions on frequency of activities performed and information related to job titles. Pearson’s chi-square test is analyzed for associations between the groups. Results Respondents returned 252 questionnaires, 233 were eligible for analysis. Research nurse activities performed internationally showed both similarities and differences. Any between country comparisons will be limited to the United States and the United Kingdom. The three most common tasks reported were recruitment 120 (51.5%), monitoring the research participant for potential adverse events 187 (80.2%) and providing nursing leadership within the interdisciplinary team 169 (72.5%). Conclusion Considering the context and range of activities of the original Clinical Research Nursing Domain of Practice, broadening the framework to include the leadership domain will better serve as a foundation for the specialty practice.

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