The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.
The Clinical Trials Office within the Masonic Cancer Center Advances in medicine and science are the results of new ideas and approaches developed through research. New cancer treatments must prove to be safe and effective in scientific studies with a certain number of patients before they can be made widely available.
About the Job:
The 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
The University of Minnesota offers a comprehensive benefits package including:
Competitive wages, paid holidays, vacation and sick leave
Low cost medical, dental, and pharmacy plans
Health care and dependent daycare flexible spending accounts
Excellent retirement plans with employer match
Disability and employer paid life insurance
Wellbeing program with reduced insurance premiums
Tuition reimbursement opportunities covering 75%-100% of eligible tuition
All required qualifications must be documented on application materials.
BS degree in Nursing and at least 2-5 years of professional nursing experience; or a combination of related education and work experience to equal nine years.
Current licensure to practice as a Registered Nurse in the State of Minnesota
Experience must include in clinical research and clinical pediatric or adult oncology/hematology
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*
Clinical Research Coordinator certification or be qualified to sit for the exam at the time of hire
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: 333605
About University of Minnesota
The Masonic Cancer Center, University of Minnesota was founded in 1991. It is part of the University's Academic Health Center, which also includes the Medical School, School of Dentistry, School of Nursing, College of Pharmacy, School of Public Health and College of Veterinary Medicine. The Masonic Cancer Center's research partners include the University's Stem Cell Institute, Center for Immunology, Center for Magnetic Resonance Imaging, and the Institute of Human Genetics; and its clinical research and treatment partners include the University of Minnesota Physicians; University of Minnesota Medical Center, Fairview; and University of Minnesota Amplatz Children's Hospital. The Masonic Cancer Center Clinical Trials Office (CTO) provides the infrastructure necessary to assist investigators in performing high-quality clinical research, insure the validity and integrity of data, and fulfill all NCI and regulatory requirements.This infrastructure includes state-of-the-art information systems and database facilities, expertise in the development and management of clinical trials, and development of IND/IDE applications and monitoring plans.The CTO provides a centralized location for al...l cancer protocols and associated correspondence with regulatory agencies including the University of Minnesota Institutional Review Board (IRB), National Institutes of Health, FDA, and Cancer Center investigator IND/IDE files.