Description
The Department of Emergency Medicine is currently seeking a Project Manager with responsibilities encompassing various aspects of regulatory compliance and project management within the General Study Team. Duties include analyzing highly complex regulatory issues and devising solutions, independently organizing and executing regulatory project plans, contributing to quality improvement initiatives and SOP development, and facilitating investigator-initiated trials including FDA submission and reporting. The role involves managing a high-volume, complex regulatory portfolio and serving as a liaison between study sponsors, regulatory agencies, investigators, and various institutional bodies to ensure protocol and regulatory compliance. Additionally, responsibilities include timely response to monitoring visits and requests, managing systems for reporting critical matters, participating in quality control activities and audits, and keeping abreast of regulatory policies. The role extends to study activation and pre-study preparation, entailing detailed protocol review, obtaining study approvals, communicating with stakeholders, and maintaining regulatory and financial documents. During study maintenance, tasks involve reviewing protocol amendments, preparing regulatory binders, submitting required reports to regulatory agencies, and coordinating monitoring visits. Upon study closeout, responsibilities include managing closeout visits, ensuring proper documentation submission, notifying relevant teams, and overseeing long-term record storage in compliance with regulations. Annul range: $78,800-$175,000