The Abramson Cancer Center Clinical Research Unit (CRU) of the University of Pennsylvania 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 D 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 a Physician Investigator (‘PI’) on clinical research performed within his/her area of interest. 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, maintain CITI training and other regulatory standards. This individual will work independently with minimal supervision.. Work directly with physicians to design, set up and execute clinical trials. May be required to speak at investigator meetings or site initiation visits for investigator-initiated trials (‘IITs’) where physician is the national PI. Assist in analyzing data to determine response and clinical outcomes; assist with literature reviews; contribute to preparation of study abstracts, posters, manuscripts and grant applications. Work in collaboration with unit manager with initiating study procedures for new ITTs and industry-sponsored clinical trials. Manage all aspects of Phase I-IV clinical trial. Participate in the conduct of audits by study sponsors, CROs, the FDA, the Eastern Oncology Group, the University of Pennsylvania’ 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 and Hospital of University of Pennsylvania staff that have eligible participants for clinical research trials. Care for subject in all age groups from young adult through geriatrics. Establishes nursing plan of care in collaboration with the PI and study team in 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, cellular immunotherapies 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 for assessment 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 clinical scope and level of expertise and referring other questions to the PI or medical team in order to obtain guidance or assistance. If needed, collect, review and report timely, valid, accurate study data with the timelines specified by the Clinical Trials Agreement. Coordination may also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g. IRB, CTSRMC, IBC and CHHPS) for initial approval, continuing review and for approval of and amendments. Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs. Act as a backup to the unit managers when required. participate in core study team, disease-site group and ongoing protocol training/compliance meetings. Participate in working groups within the disease site tam the will maximize efficiency and quality of research performed, including developing SOPs. Act as a mentor to newly hired staff. Represents the disease site team when meeting with Medical Science Liaisons, current and future research collaborators, and prospective donors; assists physician and unit manage r in coordinating development plans. Participation in national meetings, as well as University department meetings and committees. Act as a facilitator and speak at community events organized by physicians in collaboration with non-profit organizations. 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 a well as daytime visits. Position involves work-related responsibilities that may occur outside of usual hours and some conference related travel. The typical hiring salary range for a Clinical Research Nurse D in the Cancer Center is $80,000 to $90,000, depending on the successful candidate’s qualifications. Position is contingent on continued funding.
Internal Number: 39651
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