Clinical Research Nurse C/D

Clinical Research Nurse C/D

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 Genitourinary (GU) Research Team seeks a full-time, registered Clinical Research Nurse (CRN) to conduct studies involving a wide variety of investigational products and various sponsors. This position will report directly to the GU CRU Program Manager and work directly with Physician Investigators ("PI") on clinical research performed. This area of research requires dedicated attention and care to ensure participant 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. 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.
• 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. This involves a thorough understanding of disease processes, treatments, side effects, short and long-term complications. Handle any questions participants may have regarding 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.
• 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 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. 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.

Clinical Research Nurse D Responsibilities:

• The Clinical Research Nurse D will have the same duties as C but will include the following:
• This individual will work independently with minimal supervision.
• 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 Research Team.
• 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 Research 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 non‐profit organizations.

This position will require the research nurse to have a variable schedule. Research participants 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. Cross coverage and/or re-assignment amongst ACC CRU Research Teams is possible depending on business needs. Position is contingent on continued funding

Qualifications:

• The Clinical Research Nurse (CRN) is responsible for overseeing the clinical research process, research regulations, and the protocol to safeguard the participant and contribute to the science of cancer care. The successful candidate must have: (1) proven critical thinking and organizational skills to support care coordination and human subject protection; (2) a great deal of interest, enthusiasm, adaptability and willingness to learn and grow; (3) ability to prioritize nursing functions while tending to the needs of the patients; (4) strong communication skills and ability to maintain positive interactions with patients, their families and associated medical professionals in a respectful and courteous manner; (5) demonstrated initiative in learning advanced features of complex interventional programs to more effectively accomplish job duties; (6) Possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines. As well as...
• CRN C: 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. BSN degree preferred.
• CRN D: 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 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