The primary responsibility of the research nurse is to manage all aspects of conducting clinical trials. The research nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the research nurse will act as liaison between the investigators, primary care providers, the institutional review board (IRB), and the sponsor. Along with the investigator, the research nurse will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the nurse is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.

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·        The associate is aware of hospital and department compliance for federally funded healthcare programs (e.g. Medicare                 and Medicaid) regarding fraud, waste and abuse.  Brings any questions or concerns regarding compliance to the                         immediate attention of department or hospital administrative staff.

·        Purposefully conducts all aspects of the job in an ethical manner in support of the hospital’s commitment to ethical                     behavior  in all areas of personal and professional activity.

·        Successfully completes hospital-wide orientation, annual hospital competencies and department/unit specific                               competencies.

·        For the safety of our patients and co-workers, St. Luke’s Hospital requires seasonal and job related vaccinations.  This is             reviewed regularly during periodic health assessments.

·        Ensures sound conduct of the clinical trial, including but not limited to recruitment, screening, enrollment, and follow-up of           eligible subjects according to protocol requirements (e.g., subject follow-up, case report form completion, and reporting of           adverse drug experiences).

·        Maintains accurate and complete documentation, including but not limited to signed informed consent forms, source                   documentation, drug dispensing logs, subject logs, and study-related communications.

·        Organizes all aspects of the trial, including but not limited to timeliness in completing case report forms (CRFs), data                   entry, reporting adverse drug experiences (ADEs), managing caseload and managing study files.

·        Maintains communication of all protocol-related issues/problems to the appropriate management staff, including but not               limited to questions regarding the conduct of the clinical trial, concerns regarding possible ADEs or subject compliance.

·        Demonstrates professional conduct in the presence of subjects, research staff, sponsors, monitors

·        Develops and maintains enrollment/follow-up mechanisms.

·        Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility.

·        Review with the principal investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol.

·        Review and verify all relevant source documentation in the subject’s medical record to confirm study eligibility.

·        Ensure adherence to protocol requirements.

·        Maintain copies of all prescriptions written for study drug supplies, as appropriate.

·        Ensure appropriate specimen collection.

·        Attend study-related meetings as appropriate.

·        Communicate regularly with the principal investigator about study-related issues.

·        Case report form (CRF) preparation and study documentation and ensures timely and accurate CRF completion for each               study subject.

RN Required, BSN Preferred. Oncology certification or experience working within the oncology field preferred. Clinical research-related experience preferred Experience organizing multiple tasks, working with diverse groups of people. Ability to work independently and self-direct work activities. Detailed oriented and able to meet established deadlines.