(P 210) TOWARDS INTERNATIONALIZATION OF THE CLINICAL RESEARCH COORDINATOR ROLE: THE FIRST DROP OF THE NIAGARA FALLS PROJECT

Objective: The Clinical Research Coordinator (CRC) role lacks global recognition, causing unclear job description and wide EU/non-EU variation. In Italy, CRCs handle mainly administrative tasks, while in Canada, they manage patient-centered activities. This highlights the need for unified CRC responsibilities worldwide.

Methods: A collaboration between the Istituto Nazionale dei Tumori (Milan), the Italian Sarcoma Group, and Mount Sinai Hospital (Toronto) developed a 36-question survey for CRCs in sarcoma care. The survey, hosted on REDCap, covers institutional support, patient interaction/data protection, and professional context. A pilot phase (June 2025, 6 CRCs: 3 Italian, 3 Canadian) tested usability; a second phase will include a larger cohort. Results will be analyzed separately to examine cross-national CRC role differences.

Results: The pilot group completed the survey in a median of 15 minutes, with no usability issues. Results show differences in CRC roles, especially in patient interaction. Informed consent process is managed by physicians (2 Italians), jointly by CRCs and physicians (1 Italian, 1 Canadian), by nurses (1 Canadian), or CRCs alone (1 Canadian). Patient visits are scheduled by multiple staff in 83%. Direct CRC–patient contact occurs in 50%; nurses manage interactions in 33%. Data protection takes >80% of tasks in 33%, 51–80% in 17%, < 25% in 50%. One reports patient association involvement in study protocols and informed consent development. Recognition of CRC is absent for 83%, both relative to other jobs and nationally, with 50% reporting job insecurity. Unstable roles are institution-, investigator-, or donor-funded. Career and salary prospects (67%) drive intentions to leave the role. Half report the presence of boards formally supporting the CRC role, though none affiliated, showing a poor CRC role recognition.

Conclusion: Combined with phase two results (expected July 2025), findings will identify challenges to harmonizing the CRC role. A third phase may include sarcoma centers in the US, Spain, France, and Australia. The survey aims to define CRC duties crucial for improving quality, ethics, and outcomes in sarcoma trials, supporting global alignment and enhancing patient care and trial outcomes.