"Clinical Research Project Manager B"

Job Details

Clinical Research Project Manager B
University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Project Manager B Job Profile Title Clinical Research Project Manager B Job Description Summary 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 B (PM-B) 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-B 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-B 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. Job Description The PM-B 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 eight clinical research coordinators, the PM-B'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-B must have prior experience with federally funded clinical research, early onset neurodegenerative disease, and relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines. Applicants with prior experience with funding policies, NIH, and other grant procedures are preferred. The PM-B should demonstrate excellent planning, organizational and multi-tasking capabilities, effective prioritizing and problem-solving abilities, and strong communication and writing skills. Qualifications

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required. Master's degree and 3-5 years of experience preferred.

This position is contingent upon grant funding. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $74,500.00 - $95,000.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered.