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Clinical Research Nurse

2 months ago


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

We are seeking a highly skilled Clinical Research Nurse to join our team at the University of Minnesota. As a Clinical Research Nurse, 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 in pediatric and adult patient populations.

Key Responsibilities
  • Contribute to study start-up activities, including site initiation visits, protocol review, and study staff training.
  • Provide nursing expertise to interpret and operationalize the research protocol.
  • Collaborate with the Principal Investigator and study team to recruit, screen, and enroll study participants.
  • Execute study-required procedures in collaboration with clinical staff.
  • Maintain accurate source documentation, including documentation of research visits in the 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.
  • Participate in visits with sponsors, monitors, and other key collaborators, including site initiation visits, interim monitoring visits, and closeout visits.
Requirements
  • BA/BS degree in Nursing or a combination of related education and work experience to equal at least four years for Research Nurse I classification.
  • BA/BS degree in Nursing with at least two years of experience or a combination of related education and work experience to equal six years for Research Nurse II classification.
  • BA/BS degree in Nursing with at least four years of experience or a combination of related education and work experience to equal eight years (at least two years of which must be research nurse experience) for Research Nurse III classification.
  • 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.
Preferred Qualifications
  • Pediatric or adult oncology/hematology clinical experience or clinical research experience.
  • Experience with EPIC.
  • Familiarity with the University of Minnesota and MHealth Hospitals and Clinics.
  • Experience with OnCore or equivalent clinical trials management system.