Clinical Research Nurse-D

Clinical Research Nurse-D

The Clinical Research Nurse (CRN) supports all clinical research activities within the Clinical Research Unit (CRU) that require the expertise and scope of practice of a registered nurse. Reporting to the Director of Clinical Research, the CRN collaborates with investigators and study teams to ensure the safe, ethical, and compliant conduct of clinical trials. The CRN is responsible for maintaining compliance with study protocols, institutional policies, and applicable regulatory requirements while safeguarding patient safety and upholding the integrity and quality of the research program.

Position is contingent upon funding. This position is hybrid eligible after successful completion of intro period and 6 months of service.

Job Responsibilities

• Work in collaboration with Research Team Leaders and Principal Investigators with initiating study procedures for new IITs and industry-sponsored clinical trials. Manage all aspects of clinical studies and all Phases of clinical trials. Participate in the conduct of audits by study sponsors, CROs, the FDA, 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, Med Onc, surgical departments, 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 investigators and study teams that have eligible participants for clinical research trials.
• Care for participants in all age groups from children 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 the radiation oncology team in caring for participants. Creation of beacon orders and nursing worksheets as needed during study start-up. Administer or provide oversight of administration of medications, chemotherapeutic drugs, 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 PI for assessment and review, and communicate with medical staff regarding protocol-specific management of toxicities and adverse events. Triage any questions participants 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.
• Participate in study team, disease-site group and ongoing protocol training/compliance meetings. If needed, collect, review and report timely, valid, accurate study data within the timelines specified by protocol or Clinical Trials Agreement. Coordination may also include clinical activities such as performing and collecting vital signs, EKG, etc.
• Provide coverage and support to Research Project Managers and coordinators to meet CRU staffing needs. This position will require the research nurse to have a variable schedule. Research participants are seen in the clinical setting during early morning, daytime, and early evening hours. Position involves work-related responsibilities that may occur outside of usual hours or sponsored trial-related travel if required.
• Responsible for functional supervision of non licensed personnel assigned to work with the nurse. Act in lead capacity in coordination of CRU projects and assist CRU managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support. Participate in working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOPs.
• Other duties and responsibilities as assigned

Qualifications

• Bachelor's degree and 5-7 years of experience along with Registered Nurse with Licensure in Commonwealth of Pennsylvania without restriction or limitation required. BSN…