University of Pennsylvania - Philadelphia, PA

posted 2 months ago

Full-time - Manager
Philadelphia, PA
Educational Services

About the position

The GU Research Program Manager position at the Abramson Cancer Center (ACC) of the University of Pennsylvania is a pivotal role that oversees the Genitourinary (GU) Research Team within the Clinical Research Unit (CRU). The ACC is renowned for its innovative clinical trials aimed at advancing the prevention, diagnosis, and treatment of cancer. The Program Manager will report directly to the Physician Leader of the GU Research Team and will also have an indirect reporting line to the Associate Director of Clinical Research Operations. This role is essential for managing the clinical research portfolio, ensuring that all studies are conducted efficiently and in compliance with regulatory standards. The Program Manager will be responsible for the entire lifecycle of clinical trials, from study feasibility and selection to ongoing management and troubleshooting of operational issues. This includes coordinating with various stakeholders, including internal teams such as Regulatory, Education/QA, Budget, and external partners like sponsors and CROs. The Program Manager will also oversee the recruitment and enrollment of patients, ensuring adherence to protocol requirements and maintaining comprehensive documentation for all studies. In addition to managing the research team, the Program Manager will conduct regular meetings to review study statuses, address outstanding issues, and ensure balanced workloads among team members. They will also collaborate with the CRU Central to facilitate the initiation of new trials, manage regulatory activities, and develop clinical trial budgets. The role requires a strong focus on data management, including accurate data entry into the Clinical Trials Management System and monitoring study progress. The successful candidate will demonstrate effective problem-solving abilities, strong communication skills, and a solid understanding of human research protection regulations. A Master's degree and 3-5 years of relevant experience, particularly in oncology clinical research, are required for this position. This role is contingent upon continued funding and offers a hybrid work schedule, allowing for a combination of onsite and remote work.

Responsibilities

  • Oversee all aspects of the clinical research portfolio for the GU 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 CRU Regulatory coordinators to manage, review, and initiate trials.
  • Actively manage ongoing research projects and troubleshoot operational issues.
  • Supervise clinical research nurses, coordinators, and research assistants.
  • Conduct weekly meetings with team members to review study statuses and address outstanding issues.
  • Collaborate with internal and external stakeholders to develop project plans.
  • Ensure compliance with protocol requirements and maintain documentation for studies.
  • Monitor and report on the status of all studies within the group.

Requirements

  • Master's degree in a relevant field.
  • 3-5 years of related experience in clinical research, preferably in oncology.
  • Effective problem-solving abilities and strong communication skills.
  • Knowledge of IRB and human research protection regulations.
  • Strong organizational and time management skills.

Nice-to-haves

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

Benefits

  • Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits.
  • Tuition assistance for employees and their dependents.
  • Generous retirement plans with various investment options.
  • Substantial time away from work for personal needs.
  • Long-term care insurance options 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 on goods and services for faculty and staff.
  • Flexible work hours and options for remote work.
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