The Clinical Research Nurse coordinates all aspects of multiple oncology and/or hematology clinical trials. Clinical trials include Phase I-II trials under locally held INDs, as well as Phase II/III industry sponsored trials. This requires multidisciplinary skills directed towards clinical patient management and safety, protocol administration, providing education and training to research staff, clinical staff, medical providers, patients and their families.
Incumbents at this level know fundamental concepts, practices and procedures; resolve readily identifiable problems; and utilize the nursing process and standards to perform protocol-specific procedures, prevent or manage research subjects’ participation in all clinical research settings.
Administers medications and treatments, as defined by study protocol.
Conducts, coordinates and serves as a resource for various aspects of clinical trials from start-up to closeout according to study protocols.
Contributes to study start-up activities, including site initiation visits, document template creation, study staff training, and clinical in-services.
Patient recruitment, screening, consent, enrollment and necessary registrations.
Provides education to staff, subjects and families about protocols, treatment, possible side effects and complications.
Performs study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other healthcare workers.
Assists research team with routine quality control checks.
Assist with study close-out activities as directed.
Completes and submits required documentation to regulatory agencies. Identifies and assesses defined adverse events and reports to appropriate parties. May be done in collaboration with a Regulatory Specialist.
Participates in production of research publications or presentation of research data.
*These factors are used to determine the complexity of a clinical trial: Level of Disease, Level of Acuity, Independence Level of Thinking/Knowledge Level, Level of Supervision
BS degree in Nursing, current license to practice as a Registered Nurse in the State of Minnesota, AND at least 4 years of professional nursing experience, or a combination of related education and work experience to equal eight years.
Must have pediatric or adult oncology/hematology clinical experience or clinical research experience.
Experience with Word, Outlook, and web-based systems for tracking activities, calendaring, and retrieving/updating information.
Demonstrated/documented 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, pertussis and influenza are required.
Experience with pediatric or adult oncology/hematology clinical trials.
Experience with EPIC
Familiarity with the University of Minnesota, University of Minnesota Medical Center Fairview hospital and clinics
Ability to integrate clinical care with clinical research to meet the needs of the patient.
Experience with Oncore or equivalent clinical trials management system
About Masonic Cancer Center, University of Minnesota
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, the cancer center became a National Cancer Institute-designated com...prehensive cancer center in 1997, one of only 47 institutions in the United States to hold that designation.
Our research partners include the University’s Stem Cell Institute, Center for Immunology, the Center for Magnetic Resonance Imaging, the Clinical and Translational Science Center and the Physical Sciences in Oncology Center; and its clinical research and treatment partners include University of Minnesota Health Cancer Care, University of Minnesota Medical Center, and University of Minnesota Masonic Children's Hospital.
Many choose to work at the Masonic Cancer Center, University of Minnesota 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, for our excellent leadership, and we are a strong community that values diversity. For more information about MCC, its programs, research, and faculty, please visit: cancer.umn.edu.