Exploring the professional identity of clinical research nurses: A qualitative study using transformer-based semantic analysis
Mattia Bozzetti, Giorgia Petrucci, Catia Genna, Kiara Ros Thekkan, Daniele Napolitano, Rosario Caruso, Monica GubertiIAbstract
Objective:
To explore how Clinical Research Nurses in Italy define, enact, and progressively negotiate their professional identity within everyday clinical research practice.
Methods:
We conducted a descriptive qualitative interview study with transformer-assisted semantic clustering, reported in accordance with the Consolidated Criteria for Reporting Qualitative Research checklist. Semi-structured videoconference interviews were undertaken between March and August 2025 with purposively sampled Clinical Research Nurses from Italian research centres. Transcripts were anonymised. Analysis combined clustering of semantic embeddings derived from interview segments with team-based qualitative interpretation of the resulting clusters through iterative reading, contextual checking, and reflexive discussion.
Results:
Thirteen CRNs described professional identity as boundary work between protocol fidelity and person-centred care. The final thematic structure comprised two overarching themes and five sub-themes. Theme 1, “Being Between Protocol and Person: Clinical Research Nursing as Boundary Work,” included four sub-themes: acting as custodians of the participant’s trial journey; enacting the protocol in everyday clinical work; making invisible infrastructural work visible and recognised; and challenges stemming from limited involvement in organisational decision-making. Theme 2, “Building a Nursing Identity: The Path Toward a Clinical Research Role,” included two sub-themes: learning by doing through mentoring and everyday practice; and moving from ward-based nursing into research while bringing research back to clinical practice through curiosity and professional networks.
Conclusions:
Clinical Research Nurses articulate a form of translational caring that safeguards both participants and research integrity. Strengthening role recognition, providing structured education and mentoring, and including CRNs in trial governance and planning may enhance participant experience, reinforce safety processes, and support high-quality study delivery.