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Posted Job Title
Clinical Research Program Manager B (Abramson Cancer Center)
Job Profile Title
Clinical Research Program Manager 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-Cell Therapy & Transplant Research Team.
Job Description
Job Responsibilities
The Program Manager position will directly report to the Director of Clinical Research Operations of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Cell Therapy & Transplant (CTT) Research Team and indirectly report to the CTT Physician Leader and ACC CRU Central - Manager of Clinical Research Operations. The successful candidate will work closely with the CTT Director of Clinical Research Operations to oversee all aspects of the clinical research portfolio. 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, Apheresis/Stem Cell Lab) 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 CTT Research Program is supporting the varied patient population under study.
The Program Manager for the ACC CRU CTT 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 CTT 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 rep
Compensation Information:
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Up To: 0.0
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