Clinical Research Nurse C/D

About the role

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.

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.
• 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.
• Aid in analyzing data to determine response and clinical outcomes; assist with literature reviews; contribute to preparation of study abstracts, posters, manuscripts and grant applications.
• 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 participants 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 participants.
• Administer or provide oversight of administration of medications, chemotherapeutic drugs, biologic response modifiers, cellular immunotherapies and other treatment agents or study interventions, as appropriate.
• Demonstrates expertise in participant assessment related to oncology (and related diseases) and treatment as evidenced by documentation and observation.
• Obtains information and interprets it in terms of each participant’s needs.
• Must be able to prioritize urgent and routine problems including changes in participant’s condition or lab values which require immediate intervention by the PI or medical team.
• 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 participants may have regarding 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.
• Accommodate the diverse needs of our participants and their families. Provide psychosocial support and make suggestions or referrals to other professional staff (i.e. social worker, chaplain) as needed.
• Intercept and respond to participant’s phone calls and emails. Anticipates participant’s concerns and provide appropriate reassurances.
• Collect, review and report timely, valid, accurate study data within the timelines specified by the Clinical Trials Agreement.
• Obtain records required to complete case report forms.
• Update/maintain study record in the Clinical Research Management System (CRMS) in real-time.
• Maintain clinical trial databases by completing case report forms within the timelines specified by the Clinical Trials Agreement.
• These timelines may be shortened during periods of data lock or in preparation for abstract/ manuscript submission.
• May also be responsible for IND reporting and/or assisting Sponsor with annual IND reporting, and tracking site reimbursements.
• Coordination may also include: transporting specimens, submission of study documents to all applicable institutional committees (e.g., IRB, CTSRMC, IBC, CHPS) 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.

Qualifications

• Proven critical thinking and organizational skills to support care coordination and human subject protection.
• A great deal of interest, enthusiasm, adaptability and willingness to learn and grow.
• Ability to prioritize nursing functions while tending to the needs of the patients.
• Strong communication skills and ability to maintain positive interactions with patients, their families and associated medical professionals in a respectful and courteous manner.
• Demonstrated initiative in learning advanced features of complex interventional programs to more effectively accomplish job duties.
• Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
• Registered Nurse with licensure in the Commonwealth of Pennsylvania without restriction or limitation. For state licenses where Pennsylvania participates in a multi-state compact (e.g. registered nurses), a provider holding a multi-state license (MSL) would be considered to meet the requirement for Pennsylvania state licensure.
• Bachelor’s degree with 2 to 3 years of relevant experience or equivalent combination of education and experience required. Oncology experience highly preferred. Clinical research experience preferred but not required.
• Bachelor’s degree and 4 to 5 years of experience or equivalent combination of education and experience required, including 3-5 years of clinical research experience preferred. Oncology experience highly preferred.
• Master’s degree in a science-related field preferred.