University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Clinical Research Nurse

Position #: 00706321 – Requisition #: 39757

Job Summary:

The Cancer Clinical Trials Office (CCTO) at the University of Colorado Cancer Center is seeking to employ a full time Clinical Research Nurse (RN). Depending on qualifications and department needs, appointments may be made at the RN I, RN II or RN III level.

As a member of the research team this position is responsible for conducting key aspects of research for Phase I-IV industry-sponsored, co-operative group and or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. The person in this position is accountable for meeting study-specific goals and timelines, performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments within scope of practice.

Key Responsibilities:

Administrative Duties (80%)

• Assures adherence to all research standards as set forth by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer Institute (NCI) and other pertinent regulatory agencies.

• Relays timely information to Regulatory Affairs Coordinator in regard to protocols (e.g. addition of investigators, amendments, serious adverse events, consent form changes, monitoring visits, correspondence, continuing review and study termination reports) to ensure quality study flow and ensure that all governing regulations are being adhered to.

• Obtains medical history and current medications, reviews protocol inclusion/exclusion criteria, and confirms eligibility of subject. Ensures that the informed consent process has occurred, is properly documented and filed as required.

• Recruits and interviews prospective subjects for multiple clinical studies.  Familiarizes potential subjects with the details of the study through phone contacts and personal interviews.

• Schedules subject participation in research, coordinating availability of necessary space, laboratory, and physician support. Coordinates with pharmacy staff dispensing of study medication under the direction of the Principal Investigator and/or Sub-investigators.

• Assures compliance with protocol details, completes necessary records, and coordinates scheduling of subject and monitoring visits. Accurately transfers source documentation into Case Report Form (CRF) within 10 working days. Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy. Maintains patient clinical research files.

• Submits and/or manages treatment plans through the UCHealth Beacon process and works with assigned staff for completion of the treatment plan. 

• Recognizes adverse events and serious events and promptly notifies appropriate parties; e.g. Principal Investigator, Study Sponsor, FDA, Data Safety and Monitoring Committee (DSMC), Regulatory Affairs Coordinator.

• Serves as a contact person for ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of study records.