Job Description

The Research Nurse is responsible for providing nursing technical expertise and overall execution of phase I â“ III clinical trials, with an emphasis on complex cell, gene and immunotherapy trials in pediatric and adult patient populations. 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 RESPONSIBILITIES

Study Coordination & Data Management (85 â“ 100%)

● 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. 

● 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 deliver 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. 

Lead Activities â“ Research Nurse III only (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.

All required qualifications must be documented on application materials. 

Classification in the Research Nurse I, II or III role is dependent on years of relevant experience. With the exception of years of experience, the required qualifications will remain the same.

-BA/BS degree in Nursing or a combination of related education and work experience to equal at least four years for Research Nurse I (3580N1) classification.

-BA/BS degree in Nursing with at least 2 years of experience or a combination of related education and work experience to equal six years for Research Nurse II (3580N2) classification.

-BA/BS degree in Nursing with at least 4 years of experience or a combination of related education and work experience to equal eight years (at least 2 years of which must be research nurse experience) for Research Nurse III (3580N3) classification. 

Required Qualifications:

● BA/BS degree in Nursing with at least two years of experience or a combination of related education and experience to equal 6 years.

● 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 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.

About University of Minnesota Twin Cities

The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.

Connections working at University of Minnesota Twin Cities

Job Tags

Work experience placement, Interim role,

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