The primary function of a Clinical Research Nurse II (CRN) is to coordinate clinical research studies conducted at the Brown Cancer Center for Oncology/Hematology, Radiation Oncology and Blood and Marrow Transplant patients. Clinical Research at the Brown Cancer Center includes early phase, novel treatment, multi-centered, cooperative and intergroup trials, multi-institutional pharmaceutical trials, and single- or multi-centered investigator-initiated trials. The CRN facilitates compliances with the research protocol and Good Clinical Practice guidelines; uses multiple communication styles and methods to facilitate the effective coordination of clinical trials across disciplines and clinics, acting as a liaison between the principal investigator, sponsoring agent, study patients, referring physicians, pharmacist, statisticians and other members of the research team; takes leadership in ensuring an effective informed-consent process and study subject safety for the duration of the trial; ensures compliance with protocol procedures, assessments and reporting requirements; assists physicians in ensuring adequate source documentation and data-collection that validate the integrity of the clinical trial; assists in enhancing recruitment of study participants, helping with the design and implementation of recruitment strategies for identifying and assessing patients who may be eligible for a clinical trial; and the CRN demonstrates leadership in adhering to ethical principles in the conduct of clinical trials in order to protect study subjects and data integrity. Essential Duties: Coordinates all aspects of clinical trials initiation to ensure full compliance with sponsors and FDA, indirectly supervises data management with any aspect of protocol initiation coordination and data management (i.e., informed consent revisions, submissions to IRB, completion of research forms). Plans for patient recruitment methods. Screens potential patients to determine eligibility to include taking a current clinical history, reviewing patient records, assessing functional and physical status. Informs faculty of potential eligibility. Educates patients and family members regarding details of appropriate clinical trials available. Develops resources and materials for patient/family teaching. Coordinates logistics of patient visits, coordination of clinical activity including ordering/scheduling of all tests required for protocol, coordinates information between all parties for multi-modality protocols. Organizes protocol inservices for staff and data management to ensure staff understanding of specifics of each protocol. Provides inservices to department employees regularly on new studies and specific requirements for individual areas. Coordinates with medical staff to accurately reflect treatment orders for various protocols then follows the patient according to protocol schedules and data documentation. Evaluates toxicities and keeps investigators apprised of necessary modifications of each study. Assures all protocol data forms are completed in an accurate and timely manner as described by protocol guidelines, including necessary case report forms, serious adverse events and submits to IRB, sponsors and FDA as required. Maintains high level of self-education to include multi-disciplinary conferences, semiannual meetings, professional oncology meetings, workshops and other learning opportunities appropriate to research methodologies. Maintains appropriate certifications.
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