Associate Director Oncology Research Operations

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• The Associate Director Oncology Research Operations reports directly to the Senior Director of Magnet, Clinical Advancement and Community Impact at Penn Medicine Chester County Hospital0. The Associate Director works closely with the Physician Leader of the Oncology Research Team to oversee all aspects of the oncology clinical research portfolio. This employee will oversee the processes for study start-up and on-going study management from start to finish working closely with the Abramson Cancer Center One Penn Medicine Cancer Clinical Research (ADD OCCR) Regulatory coordinators to manage, review, and initiate trials to ensure competitive activation and enrollment timelines.
• The Associate Director is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team's work including, and 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 Associate Director will also work closely with major internal (PI, Regulatory, Legal, Budget, Finance, Billing Compliance, Infusion, 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 Associate Director will work with Investigators and data informatics teams / programs to ensure the Research Program is supporting the patient population they are studying overseeing Phase I-IV of clinical trials. This employee may schedule patient visits and any necessary testing, monitor patients per protocol requirements, ensure adherence to protocol requirements, and organize and maintain all documentation required by the sponsor or CRO. This employee 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 Associate Director will assist in the development / maintenance of study specific case report forms, source document tools, show vigilance in patient safety, protocol compliance and data quality. This employee must adhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.

Accountabilities

Education / Experience :