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Nurse Researcher

2 months ago

Minneapolis, Minnesota, United States University of Minnesota Full time
Job Summary

The University of Minnesota is seeking a highly skilled Clinical Research Nurse 3 to join our team. As a key member of our research team, you will be 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.

Key Responsibilities
  • Study Coordination & Data Management
    • Utilize 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.
    • Collaborate with Principal Investigators and study team to recruit, screen and enroll study participants.
    • Execute study-required procedures in collaboration with clinical staff.
    • Educate patients and clinical staff through the duration of the study regarding the treatment plan, anticipated side effects, and monitoring guidelines/follow-up.
    • Maintain accurate source documentation, including documentation of research visits in the Electronic Medical Record (EMR).
    • Coordinate and maintain a tracking system for patient visits, protocol-required data collection and other protocol procedures.
    • Identify and report serious adverse events, stopping rules and dose limiting toxicities, and protocol deviations, within institutional and sponsor required timelines.
    • Troubleshoot problems in the development and implementation of protocol procedures.
    • Participate in visits with sponsors, monitors and other key collaborators, including site initiation visits, interim monitoring visits and closeout visits.
    • Coordinate with Investigational Drug Services, BioNet, clinical staff, and other departments across campus to deliver drug, collect specimens, and execute the study visits according to protocol.
    • Work as a member of the study team with positive and timely written and verbal communication, including sharing information up, down and laterally.
  • Lead Activities
    • Mentor and train new staff, providing task-level guidance to Research Nurses I & II.
    • Serve as subject matter experts in key Clinical Trials Operations (CTO) processes, including audit preparation and conduct.
    • Manage additional workload during staff changes.
    Requirements
    • BA/BS degree in Nursing and 4 years of experience 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).