Clinical Research Nurse 3

JOB SUMMARYThe Research Nurse III is responsible for providing nursing technical expertise and overall execution of phase I - III clinical trials, with an emphasis on complex cell, gene and immunotherapy trials. This requires multidisciplinary skills directed towards clinical patient management and safety, and providing protocol-specific education to research participants and research staff. The incumbent will be expected to follow Good Clinical Practice (GCP) and all organizational policies and procedures for patient safety and data integrity, including but not limited to the Institutional Review Board (IRB), Food & Drug Administration (FDA), Code of Federal Regulations (CFR), and International Conference on Harmonization (ICH) guidelines.SPECIFIC RESPONSIBILITIESStudy Coordination & Data Management (85%)Utilizes nursing education to contribute to study start-up activities, including site initiation visits, protocol review of feasibility and suggestions for revision, study and clinical staff training.Provide 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 through 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 deliver drug, collect specimens, 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.Lead Activities (15%)Mentors and trains new staff, providing task level guidance to Research Nurses I & II.Serves as subject matter experts in key CTO processes, including audit preparation and conduct.Manages additional workload during staff changes.REQUIRED QUALIFICATIONSBA/BS degree in Nursing OR a combination of education and experience equivalent to 8 years.At least 2 years of clinical research experience.Current license to practice as a Registered Nurse in the State of Minnesota.Experience with Microsoft Office.Ability to work independently, make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies.Possess excellent communication skills; verbal and written.Flexibility with work schedule to accommodate subject visits.Proof of non-active tuberculosis and immunization for (or resistance to) measles, mumps, rubella, Hepatitis B, and pertussis (as well as any other requirements per Fairview Research Administration).PREFERRED QUALIFICATIONSExperience with EPIC.Familiarity with the University of Minnesota and MHealth Hospitals and Clinics.Experience with OnCore or equivalent clinical trials management system.

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