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Clinical Research Nurse
2 months ago
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.
- 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 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.
- 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.
