Clinical Research Registered Nurse - Hybrid - Research / Clinical Research

Company: University of Colorado
Location: Aurora
Posted on: May 23, 2023

Job Description:

Clinical Research Registered Nurse - Hybrid University of Colorado Anschutz Medical Campus Department: Cancer Center Job Title: Clinical Research Registered Nurse - Hybrid Position - Requisition #:29864 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. Examples of Work Performed by the Clinical Research Nurse (all levels) 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. Patient Care Responsibilities 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 Examples of Work Performed by Clinical Research Nurse (Level II) 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 Examples of Work Performed by Clinical Research Nurse (Level III) Serves on internal CCTO committee May be called upon for other department specific RN duties as needed Teach, precept, and mentor new employees, as directed by team manager Works on process improvement projects within the department Why Join Us: The University of Colorado Cancer Center is Colorado's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention, and cancer control. The CU Cancer Center's vision is to "prevent and conquer cancer. Together." We do this through our mission statement of "uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education." Our more than 300 renowned physicians and researchers conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive tumors who have struggled to find treatment options elsewhere. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: Diversity and Equity: The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment. Qualifications: Minimum Qualifications Clinical Research Nurse - RN I Level (Intermediate): A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field 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 Clinical Research Nurse - RN II Level (Intermediate): A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact) Two (2) years of medical/surgical or oncology nursing experience, which must include at least one (1) year of clinical research experience. Clinical Research Nurse - RN III Level (Senior): A bachelor's degree in biological sciences, nutrition, nursing, health, human services, social sciences or a directly related field from an accredited institution RN License required (Current state nursing license or RN license from a participating state in the National Licensure Compact) Three (3) years of medical/surgical or oncology nursing experience, which must include two (2) years of clinical research experience Condition of Employment - Clinical Research Nurse Level III Only: Additional certification is required for RN III at time of application OCN - Oncology Certified Nurse (obtained through ONS) Bachelor of Science in Nursing (BSN) Substitution (for all levels): Education (i.e. Associate's degree) and professional level RN experience can substitute for the Bachelor's degree on a year for year basis. Necessary Special Qualification (All Levels): Candidate must have an active RN license Candidate must have an active Colorado nursing license or ability to obtain their Colorado license prior to start date. Please include a copy of your current RN license with your submission. Preferred Qualifications CCRP - Certified Clinical Research Professional (obtained through SoCRA) CCRC - Certified Clinical Research Coordinator (obtained through ACRP) Knowledge, Skills and Abilities: Knowledge of common pharmaceutical terminology. Attention to Detail: Ability to interpret and master complex research protocol information; work is accurate and details are not overlooked. Communication Skills - Good command of the English language, and ability to communicate effectively, both written and verbal. Interpersonal Skills: Ability to establish and maintain effective working relationships with employees at all level; interacts with people in a friendly, open, honest manner; models a commitment to teamwork; demonstrates respect for the opinions of others; and maintains high level of confidentiality. Customer Service: Demonstrates a commitment to excellent customer service, providing internal and external customers with information or assistance in resolving problems. Complex Problem Solving: Identifies complex problems and reviews related information to develop and evaluate options and implement solutions. Adaptability: Adapts quickly to change and is able to manage multiple priorities and deadlines in a calm . click apply for full job details

Keywords: University of Colorado, Aurora , Clinical Research Registered Nurse - Hybrid - Research / Clinical Research, Healthcare , Aurora, Colorado