Coordinate all aspects of multiple oncology and/or hematology clinical trials for solid tumor malignancies. 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.
Incumbent at this level knows fundamental concepts, practices and procedures. Identifies and resolves readily identifiable problems. Utilizes 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
All required qualifications must be documented on application materials.
Required Qualifications: - BS degree in Nursing, current licensure 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 experience to equal eight years. - 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.
Preferred Qualifications: - 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 - Phlebotomy skills - Ability to integrate clinical care with clinical research to meet the needs of the patient. - Experience with Oncore or equivalent clinical trials management system
Internal Number: 339303
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.