This position will report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU)- Genetics Research Team. The successful candidate will work closely with Physician leader of this CRU Research Team to oversee all aspects of the clinical research being performed for their group. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study selection, prioritization of the team’s work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials. The Program Manager 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 during absences or when a specific team member’s workload exceeds capacity (including, but not limited to, managing patient visits, transporting specimens, data entry, query resolution and working with study monitors). The Program Manager for the CRU will coordinate, Phase I-IV clinical trials, Recruit, consent, screen, and enroll patients according to protocol requirements. He/she will 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 will 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 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 all University of Pennsylvania, FDA and GCP guidelines Specific responsibilities include (but are not limited to): * Supervising the clinical research coordinator(s) for the team. This will include management of staff paid time off.
* Work with research team physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources, anticipate any need for a disease group to hire additional staff based on data analysis and develop a business proposal to reflect any needs * Submit completed Initial and amendment study packets and logistical review forms to regulatory, along with appropriate study contacts * 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. * 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 * Work closely with the Regulatory Coordinators of the CRU to manage review and startup of trials * 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 * 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 * Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and other issues needing to be addressed * Monitor staff workload and work with other CRU Research Teams, the Physician Leader of the Presbyterian Research Team and the CRU Associate Director of Operations. . * Coordinate research team meetings, site initiation visits, and (as needed) monitoring visits. * The candidate will work closely with the CRU Associate Director of Operations to develop and implement SOP’s, report team study metrics, and communicate issues that may affect overall research with CRU Trials. The Program Manager may also have primary study coordinator responsibility for at least 1 study.
Internal Number: 41675
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