The Senior Clinical Research Nurse coordinates all aspects of multiple complex oncology clinical trials, including both hematological and solid tumor malignancies. Clinical trials include high risk Phase I and Phase 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 is an experienced professional serving as an expert resource and mentor to other study/protocol staff.
•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 and flow sheet 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.
•Coordinates study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records and personal communications with other healthcare workers.
•Coordinates/conducts quality control checks.
•Coordinates study close-out activities
•Ensures timely submission of study/regulatory documentation. Evaluates adverse event data and assists with making submission decisions. Recommends corrective action, as appropriate. May be done in collaboration with a Regulatory Specialist.
•Contributes to the production of research publications or presentation of research data.
•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.
BS degree in Nursing and at least 5 years of professional nursing experience or a combination of related education and work experience to equal 9 years.
Current licensure to practice as a Registered Nurse in the State of Minnesota
Experience must include 2 years in clinical research and 2 years clinical pediatric or adult oncology/hematology.
Clinical Research Coordinator certification or be qualified to sit for the exam at the time of hire.
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 adult or pediatric oncology/hematology clinical trials.
Experience with EPIC
Experience with Oncore or equivalent clinical trials management system
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.
Internal Number: 329558
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.