Clinical Research Program Manager B (Abramson Cancer Center)

$61,046 - $89,789/Yr

Hospital Of The University Of Pennsylvania - Philadelphia, PA

Full-time - Mid Level

Philadelphia, PA

Hospitals

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 Program Manager will have oversight of the ACC CRU-Cell Therapy & Transplant Research Team. 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.

Responsibilities

• Oversee all aspects of the clinical research portfolio for the CTT Research Team.
• Manage the start-to-end processes for study start-up and ongoing study management.
• Assist with study feasibility and selection, prioritization of the team's work.
• Work closely with ACC CRU Regulatory coordinators to manage, review and initiate trials.
• Actively manage ongoing research projects and troubleshoot operational issues daily.
• Assist with managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, and query resolution.
• Work with internal and external stakeholders to develop project plans and support day-to-day operations of clinical research proposals.
• Oversee Phase I-IV clinical trials and assist in recruitment and enrollment of patients according to protocol requirements.
• Schedule patient visits and necessary testing, monitor patients per protocol requirements, and ensure adherence to protocol requirements.
• Organize and maintain all documentation required by the sponsor or CRO, including source documentation and case report forms.
• 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, and coordinate study team meetings.
• Supervise clinical research staff including recruiting, interviewing, hiring, training, and performance management.
• Work with ACC CRU Central to facilitate the initiation of new trials from feasibility review to activation.
• Perform group-specific regulatory activities, including site selection visits and IRB report completion.
• Develop clinical trial budgets in collaboration with ACC Budget Specialist and Finance office.
• Ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos).
• Monitor and report the status of all studies within the group, including accrual and patient issues.

Requirements

• Bachelor's degree required and 5-7 years of related experience; or Master's degree and 3-5 years of related experience.
• Effective problem-solving abilities and 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.
• Oncology clinical research experience preferred.

Nice-to-haves

• Experience with electronic Clinical Trials Management Systems (CTMS).
• Familiarity with GCP, FDA regulations, and clinical trial processes.

Benefits

• Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
• Tuition assistance for employees, spouses, and dependent children.
• Generous retirement plans including Basic, Matching, and Supplemental retirement plans.
• Substantial time away from work for personal needs.
• Long-term care insurance for faculty and staff.
• Wellness and work-life resources to support health and balance.
• Professional and personal development resources.
• Access to University resources and cultural activities.
• Discounts and special services for faculty and staff.
• Flexible work options to promote work-life balance.