Clinical Research Nurse

University of Colorado

1d•Hybrid

About The Position

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.

Requirements

A bachelor’s degree in nursing from an accredited institution
RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact)
One (1) year of RN experience (for RN I Level)
Two (2) years of medical/surgical or oncology nursing experience, which must include at least one (1) year of clinical research experience (for RN II Level)
Three (3) years of medical/surgical or oncology nursing experience, which must include two (2) years of clinical research experience (for RN III Level)
Education (i.e. Associate’s degree) and two years of professional level RN experience can substitute for a Bachelor’s degree.
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

Nice To Haves

CCRP – Certified Clinical Research Professional (obtained through SoCRA)
CCRC – Certified Clinical Research Coordinator (obtained through ACRP)
OCN – Oncology Certified Nurse (obtained through ONS)
Additional certification is required for RN III within 1 year of appointment: OCN – Oncology Certified Nurse (obtained through ONS), CCRP – Certified Clinical Research Professional (obtained through SoCRA), or CCRC – Certified Clinical Research Coordinator (obtained through ACRP)

Responsibilities

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.
Participates in DSMC audits.
Collaborates with hospital staff to ensure tests and procedures required by clinical protocols are performed and documented. These include, but are not limited to vital signs, phlebotomy, specimen processing, EKG’s, drug administration, Infusions, pharmacokinetic sampling, toxicity checks, and protocol specific tests and procedures.
May be called upon to perform the following specific tests and procedures specifically related to the research study: a) consenting, b) electrocardiogram, c) blood pressure, pulse, height, weight, pulse oximetry, and temperature measurements, d) phlebotomy and specimen processing and shipping
Collaborates with the clinical team in developing all aspects of patient care.
Assesses patient’s pertinent health history.
Develops protocol specific source documents (e.g. data collection tools, study visit checklists, pharmacokinetic sample collection worksheets).
Assists team manager and/or financial team by processing bills and/or answering billing questions related to procedure performed for subjects enrolled to clinical trials.
Rotates through department PK (blood draw) schedule as necessary
Develop and review trial specific treatment (protocol)orders for accuracy and completeness prior to implementation in electronic medical record
Serves as primary coordinator for clinical trials
May be called upon for other department specific RN duties as needed
Teach, precept, and mentor new employees, as directed by team manager
Develop policy, procedure, patient education materials, and/or study tools as they relate to conduct of clinical research
Serves on internal CCTO committee
Works on process improvement projects within the department
Act as subject matter expert in oncology clinical trials