Project Manager, Breast Cancer Clinical Research

University of Pennsylvania Perelman School of Medicine•Philadelphia, PA

22h•$62,000 - $70,958

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 Project Manager will have support of the ACC CRU-Breast Research Team. The Project Manager position will directly report to the Lead Research Nurse and Team Manager of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU) - Breast Research Team. The successful candidate will work closely with Physician leader of this ACC CRU Research Team and Lead Research Nurse and Team Manage to oversee aspects of the clinical research portfolio being performed for their research program. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, working closely with the ACC CRU Regulatory coordinators and/or ACC CRU Central to manage, review and initiate trials to ensure competitive activation and enrollment timelines. The Project Manager is expected to actively manage ongoing research projects, troubleshoot operational issues daily and assist with any and all aspects of clinical research coordinator’s work during absences or when a specific team member’s workload exceeds capacity (including, but not limited to, managing the team member’s portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors). The Project Manager will work closely with major internal (PI, ACC CRU Central – Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to support study start up and day to day operations, as needed, of clinical research activities for their team. The Project Manager for the ACC CRU Breast Research Team will support Phase I-IV clinical trials. Additional activities may include serving as a backup to the clinical research coordinators in supporting recruitment, and enrollment of patients according to protocol requirements for their team. He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize, and maintain all documentation required by the sponsor or CRO – includes source documentation, case report forms, and research charts. He/she may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine, and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings. As needed, the Project Manager will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality and adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.

Requirements

Bachelor's Degree with 3-5 years of related experience or equivalent combination of education and experience is required.
Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations.

Nice To Haves

Oncology clinical research experience preferred.

Responsibilities

Support the Lead Clinical Research nurse with recruiting, interviewing, hiring, training and mentoring staff.
Participate in maintaining up to date records and slide sets to present at weekly or recurring meetings with team leadership and team members to review the status of the studies in feasibility and start-up, financial status of studies, and protocol amendments; as well as patients in detail, items that are outstanding, and troubleshooting issues needing to be addressed
Work with ACC CRU Central to facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with the sponsor to schedule SIVs, and maintain communication with study teams and collaborative UPHS departments regarding progress.
Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.
Work with regulatory to collect credentials documents from the study team and investigators.
Work with regulatory and the lead nurse to ensure team trainings are up to date.
Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office. Also support patient reimbursement for clinical trial participation.
May act as a back up to the clinical research coordinators in all capacities including: attending patient visits, transporting specimens, data entry, query resolution, working with study monitors, attending biopsies, and any other coordinator duty. The Project Manager may also have primary study coordinator responsibility for at least 1 study
Work closely with the Regulatory Coordinators of the ACC CRU to manage the review and startup of trials. Submit complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts.
Work with the Lead Clinical Research Nurse to closely monitor and report the status of all studies within their group, including accrual, data entry, query resolution, deviations, identification and resolution of patient issues.
Collect, review and report timely, valid, accurate study data for studies with patients on trials in long-term survival follow up. Obtain records required to complete case report forms.
Update/maintain study record in the Clinical Trials Management System (CTMS) in real-time.
Maintain clinical trial databases by completing case report forms typically within 5 business days of subject visits and resolving data queries within 10 days of issuance. The project manager will support quality assurance practices for the entire portfolio.
Work closely with the lead nurse and the study team members to organize patient charts, schedule and conduct monitoring visits, internal and external audits, and provide responses to auditing bodies following audits and monitoring visits in partnership the Lead nurse.
Collaborate with ACC CRU Central: Review of program metrics (performance, portfolio, enrollment); including quarterly Scorecard support with Breast leadership team. Timely communication of significant challenges encountered by the team.
Participate in ACC CRU Central leader meetings and serve expert work groups as needed to enhance overall workflow efficiencies and quality of research. The candidate will work closely with the Breast Lead research nurse and ACC CRU Operations Manager to develop and implement SOPs, report team study metrics, and communicate issues that may affect overall research with ACC CRU Trials.
Perform other duties as assigned

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.