Clinical Research Nurse C/D (Abramson Cancer Center)

Job Description Summary

The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 12 Research Teams that support disease/discipline specific medical oncology cancer programs within the ACC.

The Clinical and Translational Research Program for Lymphoma and Other Related Diseases (“Program”) of the University of Pennsylvania seeks a full-time, registered Clinical Research Nurse C/D to conduct studies involving a wide variety of investigational products and various sponsors. This position will report directly to the Clinical Research Nurse Supervisor and work directly with Physician Investigators (“PI”) on clinical research performed. 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.

Clinical Research Nurse C 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 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.
• 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
• 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.
• Demonstrate knowledge of patient care related to hematologic malignancies (and other related diseases), treatment, medication side effects and short and long-term complications as evidenced by documentation and observations.
• 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.
• Triage 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.
• Maintain complete, accurate, and well-organized study files from patient screening through final follow-up; disseminate valid/accurate study data to CRCs and DMs; report study data within timelines specified by the Clinical Trials Agreement.
• Maintain list of incidental deviations; contribute information to reportable deviations, other unexpected events and exception requests; assist with various regulatory submissions, respond to IRB issues or concerns, and remain aware of the regulatory statuses for assigned protocols; may be asked to contribute to study protocols and associated documents.
• Provide coverage and support to other research nurses and coordinators to meet departmental/organizational staffing needs.
• Perform other duties as reasonably assigned.

Qualifications

CRN C: Registered Nurse with licensure in the Commonwealth of Pennsylvania without restriction or limitation and 2-3 years relevant experience or an equivalent combination of education and experience required. BSN degree preferred. Bachelor's degree with 3 to 4 years of relevant experience preferred. Oncology experience highly preferred. Clinical research experience preferred but not required.

Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding

Job Location - City, State

Philadelphia, Pennsylvania

Clinical Research Nurse D Responsibilities

• This individual will work independently with minimal supervision. May act in a lead capacity or as back-up to supervisor.
• Work directly with physicians to design, set-up and execute studies. Be responsible for writing investigator initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts and grant applications.
• Independently manage complex (i.e. multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) clinical trials and registries within the Program.
• 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 in lead capacity in coordination of unit projects and assist unit managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support (e.g., regulatory submissions and data entry). 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 Program 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 non‐profit organizations.

Qualifications

CRN D: Registered Nurse with licensure in the Commonwealth of Pennsylvania without restriction or limitationand 4 to 5 years of experience or equivalent combination of education and experience required. Bachelor's degree along with 3-5 years of clinical research experience preferred. Oncology experience highly preferred. Master's degree in a science-related field preferred.

Position involves work-related responsibilities that may occur outside of usual hours and some conference-related travel. Position is contingent on continued funding

Department / School

Perelman School of Medicine

Pay Range

$51,824.00 - $105,000.00 Annual Rate