• Supports multiple complex clinical research studies • Plans, develops and prepares all required regulatory documents • Supports submissions to ancillary committees • Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions • Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout • Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events • Maintains study level documentation for all studies • Ensure files are audit ready • Monitors compliance required documentation • Enters and maintains study information and regulatory approvals in electronic systems • Provides guidance and training to research staff to ensure compliance with highly complex regulations • Attends and participates in educational programs, meetings and assigned committees • Participates in the development and implementation of quality improvement and quality assurance activities