Clinical Research Project Manager A (Department of Neurology)

This position is based in the Penn Frontotemporal Degeneration Center (FTDC), part of the Department of Neurology of the University of Pennsylvania's Perelman School of Medicine. The Penn FTDC which is a large translational research center with federally funded (NIH, NIA, etc.), foundation funded, and industry funded clinical and non-clinical research projects, including early phase, complex clinical trials and large federal grants, supporting a robust research program studying patients with rare early-onset neurodegenerative disease. The FTDC is seeking a Clinical Research Project Manager A (PM-A) who will be responsible for day-to-day management and oversight of the FTDC's federally funded observational research portfolio focused on young onset neurodegenerative diseases including frontotemporal degeneration (FTD), Alzheimer’s disease and related dementias. The PM-A will work with the FTDC Clinical Research Program Lead and other project managers to oversee clinical research projects through their entire lifecycle (startup, conduct, closeout). The PM-A will function in a lead capacity while overseeing existing project activities for the core research program and support the implementation of new projects in accordance with federal regulations, institutional policy and established timelines. This position will report directly to the FTDC Clinical Research Program Lead, the Clinical Co-Director of the Penn FTDC and indirectly to the other Co-Directors and PIs within the Penn FTDC. The PM-A will oversee all clinical visit activities including recruitment, enrollment, collection and processing of study data and biological samples, data entry and queries, and completion of monitoring and closeout visits. Supervising up to six clinical research coordinators, the PM-A's scope includes but is not limited to supportive oversight of study teams, study conduct and study closeout; active management of ongoing longitudinal projects; ensuring protocol compliance in accordance with established timelines, institutional policies, federal regulations and good clinical practices; prioritizing efforts of the study team; overseeing timely and accurate data collection, research billing, assisting the Clinical Research Program Lead with developing and updating center processes and standard operating procedures; assisting with staff on-boarding and ongoing training activities, assisting in interviewing CRC hiring candidates, management of essential and source documentation, management of recruitment, enrollment, and retention of subjects, management of invoicing per protocols as relevant, oversee human subject protection policies and procedures, troubleshooting operational issues, assisting with all aspects of research coordinators’ work during absences or when a coordinator’s workload exceeds capacity. The position may require communication with patients and staff outside of office hours. Hours are flexible to adapt to protocol requirements, and may include evenings or weekend as necessary. The PM-A must have prior experience with federally funded clinical research. Applicants with prior experience with early onset neurodegenerative disease, relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines, funding policies, NIH, and other grant procedures are preferred. The PM-A should demonstrate excellent planning, organizational and multi-tasking capabilities, effective prioritizing and problem-solving abilities, and strong communication and writing skills.