Clinical Research Nurse Supervisor

University of Pennsylvania•Philadelphia, PA

12d•Hybrid

About The Position

The Clinical Research Nurse Supervisor will report directly to the Director of RadOnc CRU. Provides leadership in the coordination of IIT and federal or industry sponsored clinical studies/trials. Oversees study/trial start-up, conduct, and close-out. In charge of Beacon built/order, AE/SAE assessment. Ensure study/trial data integrity and regulatory compliance with GCP guidelines, Federal/FDA regulations, and institutional/sponsor requirements. Supervise CRCs and CRNs as assigned. Supporting project timelines & preparing for monitoring and audit visits.

Requirements

BSN degree and 5+ years or MSN with 3+ years of experience with Registered Nurse and Licensure in Commonwealth of Pennsylvania without restriction or limitation required.
Position is contingent upon funding.

Responsibilities

Work with CRU leadership and Principal Investigators to initiate new IITs and industry-sponsored clinical trials in the department.
Manage assigned clinical studies and Phase I–IV clinical trials.
Assist with protocol development to ensure logistical feasibility of study related procedures and work-flow.
Prepare study SOP, documents (e.g., visit guides, source document), subject binders, tracking logs for study start up.
Assist with new study budgeting and manage active study invoicing as appropriate.
Train and Supervise CRCs and CRNs as assigned.
Determine workload and assignments for your team.
Responsible for or participate in the hiring and performance management of staff.
Provide training and oversight to network sites as assigned.
Orient and mentor new unit staff and function as resource for current staff.
Oversee study/trial implementation, including treatment, follow-up visits and procedures, data collection, concomitant medications, and adverse events, etc.
Ensure proper documentation, assessment, and reporting of AE/SAEs to study/trial Sponsor and all applicable institutional or study related committees according to regulations and requirements.
Prepare for and participate in monitoring or audit visits conducted by study sponsors, CROs, the FDA, the University of Pennsylvania’s OCR, ACC DOCM, and other regulatory groups.
Coordinate the administration of the investigational product and study related medications including creation of beacon built/orders and nursing worksheets, obtaining orders, administration dates, monitor the administration of study related medications and subject safety.
Work with clinical team in caring for participants as appropriate.
Participant in study team, disease-site group and ongoing protocol training/compliance meetings.
Address queries in timely manner.
Other responsibilities may include training, performing, and collecting vital signs, EKG, PK sampling, etc.
Communicate with multidisciplinary teams to ensure study activation and implementation per protocol.
Provide education updates to investigators and trainings to study teams.
Attending standing and adhoc meetings as required.
Other duties and responsibilities as assigned.

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.