The Abramson Cancer Center Clinical Research Unit (CRU) of the University of Pennsylvania at Penn Presbyterian Medical Center seeks a registered nurse with licensure and in good standing to practice in the Commonwealth of Pennsylvania to provide comprehensive professional nursing care in a multi-disciplinary environment. The Clinical Trials Nurse C at Penn Presbyterian Medical Center is responsible for conducting studies involving a wide variety of investigational products and various sponsors. This position will report to the unit managers of a specific disease-site and work directly with Physician Investigators on clinical research. This area of research requires dedicated attention and care to ensure subject safety and well-being. The successful candidate will comply with all policies relating to UPHS, JCAHO, GCP and other regulatory standards. * Assist with initiating study procedures for new investigator-initiated (‘IITs’) and industry-sponsored clinical trials. Manage all aspects of Phase I – IV clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, the Eastern Oncology Group, the University of Pennsylvania’s CTSRMC, and other groups. * Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, Advanced Practitioners, triage, inpatient and pharmacy. Provide in-service and support to infusion, CHPS or inpatient staff as appropriate. Provide ongoing service education updates to all investigators that have eligible participants for clinical research trials. * Care for subjects in all age groups from young adult through geriatrics. Establishes nursing plan of care in collaboration with the PI and study team and in accordance with research guidelines and GCP. Coordinate activities of oncology team in caring for subjects. Administer or provide oversight of administration of medications, chemotherapeutic drugs, biologic response modifiers, and other treatment agents or study interventions, as appropriate. * Review all clinical and laboratory data and adverse events, reporting in real-time to the Principal Investigator (PI) for assessment and review, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events. * Handle any questions subjects may have regarding protocol specifics, investigational products, lab results, effects of therapies, medications, and symptom management within level of expertise and referring other questions to the PI or medical team in order to obtain guidance or assistance. * Collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement. Coordination will also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g. IRB, CTSRMC, IBC, CTRC) for initial approval, continuing reviews and for approval of any amendments. * Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs. * Participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Participate in working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOP’s. Act as a mentor to newly hired nurses. This position will require the research nurse to have a variable schedule. Research subjects are seen in the clinical setting during early morning and early evening hours as well as daytime visits. Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel.
Position is contingent on continued funding.
Internal Number: 41487
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