The Developmental Therapeutics Clinical Research Program at the Abramson Cancer Center at the University of Pennsylvania seeks a registered nurse with licensure in the Commonwealth of Pennsylvania to manage dedicated research support staff and to oversee the everyday clinical-aspect of research operations within the Developmental Therapeutics Clinical Research Program. The Lead Nurse will report directly to the Director of Developmental Therapeutics Clinical Research Program, Dr. Peter O’Dwyer, and will work in collaboration with the Developmental Therapeutics Clinical Research Program Manager. In addition, the Lead Nurse will be responsible for managing a research patient caseload for various protocols in accordance with GCP guidelines. The essential functions of the position include but are not limited to:
* Independently coordinate all aspects of Phase I – IV oncology clinical trials. Coordination of trial activities will include, but is not limited to, obtaining informed consent, screening and enrollment of study participants, confirming eligibility and registration of subjects, scheduling study related visits (e.g., lab tests and procedures), administer or coordinate administration of medications and treatments, study drugs and interventions, including injections; blood drawing, including blood draws via venipuncture and through accessing lines and ports, conduct study and subject assessments; monitor patient care, assess patient status, monitor treatment side effects, non-serious and serious adverse event reporting; assure protocol compliance; collect data and maintain source data documentation, ensuring completion of source documents and case report forms (CRFs), resolve queries, conduct initiation, monitoring audit and closeout visits with sponsors. Provide in-service and support to infusion, CHPS or inpatient staff as appropriate. Intercept and respond to trial participant’s telephone calls and emails. Provide patient/family education and support. Participate in study- and patient-related discussions in-person or via email or telephone with the sponsor or PI that may occur outside of usual work hours. Coordination may also include, but often to a lesser degree, the 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, maintenance of regulatory files, preparation for monitoring visits and audits, and assisting Sponsor with annual IND reporting. * The Lead Nurse will mentor and supervise 15+ research personnel composed of Research Nurse Practitioners, Nurses, Coordinators, Data Managers, Liaisons and Assistants. This includes day-to-day, annual performance evaluation, PTO approval and electronic timesheets management. Coordinate staff coverage or provide coverage as needed. * The Lead Nurse is a point-of-contact for triage, laboratory, clinic, infusion, radiology, advanced practitioners, inpatient, billing and pharmacy when research staff is unavailable or when issues involve escalation. Is a point of contact for evenings, weekends and University holidays if questions arise or for research admissions. Troubleshoot operational issues on a daily basis and assist with any and all aspects of research during absences or when a specific team member’s workload exceeds capacity. This includes, but is not limited to: managing patient visits, transporting specimens, data entry, query resolution and working with study monitors. * In collaboration with the Developmental Therapeutics Clinical Research Program Manager (PM), the Lead Nurse will maintain staff by recruiting and interviewing full-time, part-time and temporary-extra staff. Support Clinical Research Unit (CRU) throughout new-hire orientation period whereby staff complete required university training, department training, HIPAA, GCP, CITI, EMR, etc. The Lead Nurse will provide disease- and study-specific training that is tailored to the needs of the individual and his/her role within the research program (Research Nurse Practitioner, Nurse, Coordinator, Data Manager, Liaison and or Assistant). Maintain an instructional plan for all new hires, which includes training documentation as well as the establishment of performance or competency standards. Build and implement a nursing-specific professional development program that includes written competencies to ensure understanding of skills with the goal of maximizing the efficiency and quality of research performed within the program. * Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed. Attend project manager meetings with CRU to develop and implement disease-site specific initiatives. Participate in site-selection visits, site initiations visits and monitoring visits as needed. * In collaboration with the PM, the Lead Nurse will develop tools and organization structures to support the program including standard operating procedures and guidelines for research personnel. Organize monthly focus groups with research staff to foster continual learning and promote growth within the program. Organize seminar series for Developmental Therapeutics clinical research staff featuring topics pertinent to developing and conducting research at ACC. * Develop new studies along with the leaders of the Developmental Therapeutics Clinical Research Program. Represent the Developmental Therapeutics Clinical Research Program when meeting with Medical Science Liaisons, current and future research collaborators, and prospective donors; assists Dr. O’Dwyer and the PM in coordinating development plans. * The Lead Nurse will maintain professional and technical knowledge by attending educational workshops and national meetings, reviewing professional publications, establishing personal networks, and benchmarking state-of-the-art practices; ensure that colleagues are updated on all relevant issues. * The Lead Nurse will provide clinic support to Principal Investigator as needed. Perform additional duties as assigned.
Registered nurse with licensure in the Commonwealth of Pennsylvania and 4-5 years of nursing experience, including 2-3 years of clinical research experience, is required. Bachelor degree in Nursing or a related discipline and oncology experience (either nursing or clinical research) is highly preferred. Experience managing staff and the ability to support faculty with tact, confidentiality and judgment. Position contingent upon funding.
Internal Number: 45215
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