About the Job:
The Department of Medicine is hiring a Clinical Research Coordinator Nurse (CRC-RN) to support the clinical research projects conducted by the department’s Research Operations and Resources (ROAR) Team. The Department of Medicine is one of the top research departments in the United States and represents the largest research faculty group at the University of Minnesota. The MED ROAR Team supports a high volume of varied research projects across 11 divisions.
The primary purpose of this position is to independently coordinate clinical research studies according to regulatory requirements, institutional guidelines, and sponsor expectations and to provide nursing technical expertise. Duties are determined by protocol-specific requirements and may include initiating new trials, screening patients for eligibility, coordinating the enrollment of eligible patients, extracting and reporting accurate patient data, managing lab samples/specimens, and responding to data queries. This position is accountable to the physician-investigators and members of the clinical research team.
This position can support a hybrid work schedule, with the majority of days working in-person and will vary depending on the research study assignments. The position has flexible work hours and could include some early mornings, evenings, and weekends as needed for studies.
Study Coordination & Data Management (100%)
Utilizes nursing education to contribute to study start-up activities, including site initiation visits, protocol review of feasibility, study and clinical staff training.
Provides nursing expertise to interpret and operationalize the research protocol.
Collaborates with PI and study team to recruit, screen and enroll study participants.
Executes study-required procedures in collaboration with clinical staff.
Educates patients and clinical staff throughout the duration of the study regarding the treatment plan, anticipated side effects, and monitoring guidelines/follow-up.
Maintains accurate source documentation, including documentation of research visits in the EMR (e.g. consent/re-consent, adverse events, concomitant medications, protocol-related education, etc.).
Coordinates and maintains a tracking system for patient visits, protocol-required data collection and other protocol procedures.
Identifies and reports serious adverse events, stopping rules and dose limiting toxicities, and protocol deviations, within institutional and sponsor required timelines.
Troubleshoots problems in the development and implementation of protocol procedures.
Participates in visits with sponsors, monitors and other key collaborators, including site initiation visits, interim monitoring visits and closeout visits.
Coordinates with Investigational Drug Services (IDS), BioNet, clinical staff, and other departments across campus to manage study drug, collect biospecimens, and execute the study visits according to protocol.
Works as a member of the study team with positive and timely written and verbal communication, including sharing information up, down, and laterally.
The employer reserves the right to change or assign other duties to this position.