Multi-Institution Project Manager

University of Pennsylvania•Philadelphia, PA

11d

About The Position

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 cancer programs within the ACC. This Multi-Institution Project Manager will have oversight of the ACC CRU- Lymphoma Research Team’s Therapeutic Multi-Institution portfolio. The Project Manager position will directly report to the ACC CRU- Lymphoma Research Program Manager and indirectly report to the Physician Leader of the ACC CRU- Lymphoma Research Team. Initial work will focus on supporting current multi-site efforts within ACC CRU- Lymphoma’s Investigator-initiated trial (IIT) portfolio and management of upcoming multi-site therapeutic opportunities where PCAM/HUP is the lead site. Responsibilities may include overseeing faculty-held IND projects. The successful candidate will work closely with Physician Investigators, the Program Manager, Lead Research Nurse, and other IIT Sponsor/Site team members as delegated to oversee all aspects of our multi-site IITs, including start-to-end processes for study start-up and ongoing study management for these projects. This includes troubleshooting operational issues as they arise, working closely with internal and external stakeholders to ensure patient safety/adherence to the protocols and to support important project goals/endpoints.

Requirements

The minimum of a bachelor’s degree (in a relevant discipline, biological sciences preferred) and 5 to 6 years of experience or an equivalent combination of education and experience is required, master’s degree (in a relevant discipline) and 3 to 4 years of experience, or equivalent combination of education and experience is preferred.
Experience in a hospital academic medical setting or pharmaceutical experience with principal responsibilities related to the direct conduct of clinical trials and/or research operations is required.
Thorough knowledge of GCP, and relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.
Demonstrated project and time management skills are necessary; must be able to work independently with minimal supervision.
Outstanding organizational skills and the ability to function in a team environment.
Qualified candidates must also demonstrate excellent written and verbal communication skills; advanced computer software skills; must be able to work in a fast-paced environment with time sensitive deadlines and competing priorities; the ideal candidate will have very strong analytical and critical thinking skills, and the ability to build and maintain positive working relationships at all levels of the institution and external collaborators/sites.
Position is contingent upon continued funding.

Nice To Haves

Oncology clinical trial experience preferred.

Responsibilities

This individual will be responsible for coordinating and facilitating all elements of study planning, implementation and operations at external enrollment sites, including, but not limited to: Study start-up, daily operations, external site communications, recruitment and enrollment, and troubleshooting; Quality Assurance & Quality Control; study activation and close out activities.
Create and review regulatory submissions.
In collaboration with Principal Investigators, research team leaders, and delegated IIT team members, develop and review study documents/tools, including protocols, consents, annual reports, source documents, training slides, Study Manual of Procedure (MOP), DSMB charter, and Case Report Forms (CRFs).
Assist with IND/IDE/CTA exemption determinations.
Provide ongoing administrative and operational support to PI’s related to multi-site projects.
Attend, create presentations for, and coordinate meetings (e.g. physician feasibility discussions, Site Initiation Visits, trainings, etc.).
Generate and provide data and reports as necessary for study endpoints and publications.
Assist with training of direct and/or indirect research staff in study procedures as required by protocol(s). Includes data and lab management, protocol compliance and QC/QA.
Serve as the primary contact for all sites for any study related issues; escalate to research team leaders as needed.
Ensure adherence to study timelines and protocol/procedures.
Assist with pre-award finance activities (driving contract timelines, budgeting input or development, grant writing assistance); and/or post-award finance activities (invoicing, billing review)
Demonstrate vigilance in patient safety, protocol compliance and data quality.
Adhere to all University of Pennsylvania, IRB, CTSRMC, FDA, applicable Federal, State and Local, as well as GCP guidelines.

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.