Job Description
Job Description
The Research Nurse II is responsible for providing nursing technical expertise and overall execution of clinical trials, with an emphasis on later phase (II-III) clinical trials and an introduction to phase I trials. 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.
SPECIFIC RESPONSIBILITIES Study Coordination & Data Management (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.
All required qualifications must be included in the application materials REQUIRED QUALIFICATIONS - 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
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.
Pay Range: $78,000 - $95,000; depending on education/qualifications/experience
Time Appointment : 100% Appointment
Position Type : Civil-Service & Non-Faculty Labor Represented Staff
Please visit the Office of Human Resources website for more information regarding benefit eligibility.
The University 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 Regents Tuition Benefit Program
- 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) opportunity
- Financial counseling services
- Employee Assistance Program with eight sessions of counseling at no cost
- Employee Transit Pass with free or reduced rates in the Twin Cities metro area
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 and uploading documents in the "My Cover Letters and Attachments" section.
To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647.
Job Tags
Interim role, Work at office, Flexible hours,