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University of Pennsylvania · 1 day ago

Clinical Research Project Manager B

HUP

Full-time

Onsite

Senior Level

$74K/yr - $95K/yr

5+ years exp

The University of Pennsylvania is a prestigious Ivy League institution located in Philadelphia, recognized for its leadership in education and research. They are seeking a Clinical Research Project Manager B to manage and oversee federally funded observational research focused on neurodegenerative diseases, ensuring compliance with regulations and supporting project activities throughout their lifecycle.

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Responsibilities

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

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

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

Qualification

Clinical research managementNeurodegenerative disease knowledgeRegulatory complianceData collectionProject oversightMulti-tasking abilitiesCommunication skillsOrganizational skillsProblem-solving skills

Required

Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience is required

Prior experience with federally funded clinical research

Experience with early onset neurodegenerative disease

Knowledge of relevant regulations for the conduct of clinical research including Title 21 Code of Federal Regulations (CFR) and International Conference of Harmonization (ICH) Guidelines

Demonstrate excellent planning, organizational and multi-tasking capabilities

Effective prioritizing and problem-solving abilities

Strong communication and writing skills