Abramson Cancer Center CRU Leukemia Program Manager - Philadelphia, United States - University of Pennsylvania

Description

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Posted Job Title

Abramson Cancer Center CRU Leukemia Program Manager

Job Profile Title

Manager Research Project B

Job Description Summary

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 Program Manager will have oversight of the ACC CRU-Leukemia Research Team.

Job Description

The Program Manager position will directly report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Leukemia Research Team and indirectly report to the ACC CRU Associate Director Research Operations.

The successful candidate will work closely with Physician leader of this ACC CRU Research Team to oversee all 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, prioritization of the team's work, working closely with the ACC CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive activation and enrollment timelines.

The Program Manager is expected to actively manage ongoing research projects, troubleshoot operational issues daily and assist with any and all aspects of their team's work during absences or when a specific team member's workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors).

The Program 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 develop project plans and support day to day operations of clinical research proposals for their team.

The Program Manager will work with Investigators and data informatics teams/programs to ensure the Leukemia Research Program is supporting the patient population they are studying.

The Program Manager for the ACC CRU Leukemia Research Team will oversee Phase I-IV clinical trials. Additional activities may include 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.

The Program 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.

Adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.

Specific responsibilities include (but are not limited to):

• Supervising the clinical research nurse(s), clinical research coordinator(s), and research assistants for the Leukemia Research team. This will include recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed
• Work with research team physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources in conjunction with available patient population statistics, anticipate any need for the group to hire additional staff based on data analysis and develop a business proposal to reflect any needs
• 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 sponsor to schedule SIV's, 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 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.
• Work closely with the Regulatory Coordinators of the ACC CRU to manage 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 team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events, and subject enrollment status. The Program Manager may also have primary study coordinator responsibility for at least 1 study.
• Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations, and patient issues, identifying and addressing any issues
• Collaborate with ACC CRU Central:
• Review of program metrics (performance, portfolio, enrollment)
• Timely communication of significant challenges encountered by the team
• Participate in ACC CRU Central leader meetings and serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research.
• The candidate will work closely with the ACC CRU Manager of Operations to develop and implement SOP's, report team study metrics, and communicate issues that may affect overall research with ACC CRU Trials.
• Perform other duties as may be assigned

QUALIFICATIONS:

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.

Master's degree and 3-5 years of related experience or an equivalent combination of education and experience required. Oncology clinical research experience preferred.


POSITION CONTINGENT UPON CONTINUED FUNDING
Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$61, $95,524.00 Annual Rate

Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.

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University Benefits

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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.

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

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Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries.

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• 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.

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