Job ID360139 LocationTwin Cities Job FamilyResearch-Nursing Full/Part TimeFull-Time Regular/TemporaryRegular Job Code3580N2 Employee ClassCivil Service About the Job JOB SUMMARY The Research Nurse 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 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. Classification in the Research Nurse 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. Must have at least 6 years of relevant education and work experience for the Research Nurse II (3580N2) classification Must have at least 8 years of relevant experience and education AND at least two years of research nurse experience for Research Nurse III (3580N3) classification. SPECIFIC RESPONSIBILITIES Study Coordination & Data Management (85% - 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 - 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. Qualifications All required qualifications must be included in the application materials REQUIRED QUALITIFICATIONS * BA/BS degree in Nursing plus at least two years of experience OR a combination of education and experience equivalent to 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 the Department The Masonic Cancer Center creates a collaborative research environment focused on the causes, prevention, detection, and treatment of cancer applying that knowledge to improve quality of life for patients and survivors and sharing its discoveries with other scientists, students, professionals, and the community. Founded in 1991, MCC became a National Cancer Institute-designated comprehensive cancer center in 1998 and is now one of only 50 institutions in the United States to hold this designation, which is awarded only to institutions that make ongoing, significant advances in cancer research, treatment, and education. Many people choose to work at the University of Minnesota MCC because they believe in our mission and are excited by our vision for the future. We have a reputation as a great place to work with excellent leadership and a strong community that values diversity. The University of Minnesota provides a very competitive benefits package and access to many resources and professional development opportunities. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer contribution Public Service Loan Forgiveness (PSLF) Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost with free or reduced rates in the Twin Cities metro area Please visit the for more information regarding benefits. How To Apply Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.