Clinical Research Nurse II

University of Louisville•Aurora, CO
•$68,711 - $103,067•Onsite

About The Position

The Clinical Research Nurse II coordinates clinical research studies conducted at the Brown Cancer Center for Oncology & Hematology, Radiation Oncology, and Blood and Marrow Transplant patients. Studies include early-phase, novel-treatment, multicenter, cooperative and intergroup trials, pharmaceutical trials, and investigator-initiated trials. The role facilitates compliance with research protocols and Good Clinical Practice guidelines and coordinates clinical trials across disciplines and clinics, serving as a liaison among investigators, sponsors, study patients, referring physicians, pharmacists, statisticians, and other research team members. The nurse leads the informed-consent process and helps protect study-subject safety throughout each trial. The position ensures compliance with protocol procedures, assessments, and reporting; supports source documentation and data collection; contributes to recruitment strategies; and upholds ethical principles to protect participants and data integrity. The position coordinates trials from initiation through required data management and reporting, screens and educates potential participants and their families, coordinates protocol-related patient visits and tests, and supports staff understanding of study requirements through training. It also monitors patients according to protocol schedules, evaluates toxicities, communicates with investigators about necessary modifications, and maintains professional education and applicable certifications. The selected candidate's hire date will be effective no earlier than January 5, 2027.

Requirements

  • Bachelor's degree in Nursing.
  • Current Kentucky nursing license.
  • Two years of related research or nursing experience.
  • If not already ACRP- or SoCRA-certified, obtain certification within the first three years.
  • Maintain appropriate certifications.

Nice To Haves

  • ACRP or SoCRA certification in Clinical Research.
  • OCN certification.

Responsibilities

  • Coordinate all aspects of clinical trial initiation to ensure compliance with sponsors and the FDA, including protocol coordination and related data-management activities such as informed-consent revisions, IRB submissions, and research forms.
  • Plan patient-recruitment methods; screen potential patients for eligibility by taking clinical histories, reviewing records, and assessing functional and physical status; and inform faculty of potential eligibility.
  • Educate patients and family members about appropriate clinical trials and develop patient and family teaching resources and materials.
  • Coordinate patient-visit logistics and clinical activities, including ordering and scheduling protocol-required tests and coordinating information among parties for multimodality protocols.
  • Organize protocol in-services for staff and data-management personnel and regularly provide department employees with training on new studies and area-specific requirements.
  • Coordinate with medical staff to accurately reflect treatment orders for protocols, follow patients according to protocol schedules, evaluate toxicities, and keep investigators informed about necessary study modifications.
  • Ensure protocol data forms are completed accurately and on time, including case report forms and serious adverse-event reports, and submit required materials to the IRB, sponsors, and FDA.
  • Maintain professional education through multidisciplinary conferences, semiannual meetings, oncology meetings, workshops, and other learning opportunities relevant to research methodologies; maintain appropriate certifications.
  • Facilitate protocol and Good Clinical Practice compliance, effective communication across disciplines, informed consent, participant safety, and ethical conduct of clinical trials.
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