CLINICAL TRIALS RESEARCH NURSE
Duties: 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 and other regulatory standards. This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to the supervisor.
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 managers with initiating study procedures for new 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 and HUP staff 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, 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 (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.
If needed, collect, review and report timely, valid, accurate study data within 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, 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. Responsible for functional supervision of non-licensed personnel assigned to work with the nurse. Act as a back-up 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 team that will maximize the 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 manager 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 the Leukemia & Lymphoma Society and other 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 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.
Qualifications: Registered Nurse with licensure in the Commonwealth of Pennsylvania without restriction or limitation and 4-5 years of experience or equivalent combination of education and experience required. 3 to 5 years of clinical research experience required. Oncology experience highly preferred. BSN degree or Master's degree in a science-related field preferred.
CPR certification required. Position requires ability to perform phlebotomy, accessing central lines and peripheral IV insertion in addition to the following:
(1) a great deal of interest, enthusiasm, adaptability and willingness to learn and grow.
(2) proven organizational skills.
(3) ability to prioritize nursing functions while tending to the needs of the patients.
(4) ability to maintain positive interactions with patients, their families and associated medical professionals in a respectful and courteous manner.
(5) ability to uphold the department's goal of exceptional patient satisfaction and use all resources to maintain positive patient experiences;
(6) demonstrated initiative in learning advanced features of programs to more effectively accomplish job duties.
Reference Number: 40-27683
Salary Grade: 028
Employment Type: Exempt
Org: CC-Cancer Center
Job Family: J-Technical/Professional Medicine/Health