Clinical Research Nurse Project Manager (Department of Radiation Oncology)

University of Pennsylvania•Philadelphia, PA

21d•Hybrid

About The Position

The Clinical Research Nurse Project Manager will support all aspects of clinical research activities in the CRU that requires RN involvement, will directly report to the Director of Clinical Research. This position provides leadership in the coordination of clinical trials & projects. Oversees study approvals, participant enrollment & consent, visit scheduling, medication administration, data collection, & regulatory compliance with institutional & sponsor requirements. Position is contingent upon funding.

Requirements

Registered Nurse with 4-6 years of experience with Licensure in Commonwealth of Pennsylvania without restriction or limitation required, including 3-5 years of clinical research experience preferred.
Position is contingent upon funding.

Nice To Haves

BSN preferred.
Oncology experience highly preferred.
Registered Nurse with 5-7 years of experience with Licensure in Commonwealth of Pennsylvania without restriction or limitation required, including 3-5 years of clinical research experience preferred.
7-10 years of preferred experience.
BSN or MSN preferred.
Oncology experience highly preferred.

Responsibilities

Collaborate with Research Team and Principal Investigators to initiate study procedures for new investigator-initiated trials (IITs) and industry-sponsored clinical trials.
Serve in a Clinical Research Nurse (CRN) role to coordinate, implement, and manage assigned clinical studies and Phase I–IV clinical trials.
Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow.
Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up.
Assist with new study budgeting and manage active study invoicing as appropriate.
Provide direct supervision & management to Clinical Research Coordinator(CRC)s within the assigned team and any CRNs if applicable.
Determine workload and assignments for team staff.
Responsible for or participate in the hiring and performance management of staff.
Provide training and oversight to network sites on the assigned studies.
Orient and mentor new unit staff and function as resource for current staff.
Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures.
Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events.
Ensure proper evaluation, documentation, reporting of SAEs and AEs of studies to the Sponsor and all applicable institutional or study related committees and personnel according to applicable regulations and policies.
Prepare for and participate in audits conducted by study sponsors, CROs, the FDA, the University of Pennsylvania’s CTSRMC, and other regulatory groups.
Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions.
Coordinate activities of the radiation oncology team in caring for participants.
Creation of beacon orders and nursing worksheets as needed during study start-up.
Provide oversight of administration of medications, chemotherapeutic drugs, cellular immunotherapies, and other treatment agents or study interventions, as appropriate.
Participate in study team, disease-site group and ongoing protocol training/compliance meetings.
If needed, collect, review and report timely, valid, accurate study data within the timelines specified by protocol or Clinical Trials Agreement.
Coordination may also include clinical activities such as performing and collecting vital signs, EKG, PK sampling, etc.
Develop and maintain ongoing communication with the clinical teams including, but not limited to: laboratory, infusion, radiology, MedOnc, surgical departments, 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 investigators and study teams that have eligible participants for clinical research trials.
Responsible for functional supervision of non licensed personnel assigned to work with the nurse.
Act in lead capacity in coordination of CRU projects and assist CRU managers in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support.
Participate in working groups within the disease-site team that will maximize the efficiency and quality of research performed, including developing SOPs.
Additional Duties as assigned.
Participate in development of unit based standard operating procedures (SOP) and guidance documents, reviewing clinical sections of new protocols and amendments for logistical feasibility.
Collaborate with other management personnel in meeting departmental and programmatic objectives.

Benefits

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.
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.
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.
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.
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.
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.
Penn provides an array of resources to help you advance yourself personally and professionally.
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.
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 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 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.
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.