Clinical Research Nurse, C/D

Role Overview

• 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.
• 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.
• 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.

Requirements

• 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
• 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
• 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

Tech Stack

• Google Cloud Platform

Benefits

• Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
• Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
• Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
• Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
• Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
• Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
• Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
• University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
• Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
• Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
• Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
• Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.