Title:  Senior Coordinator, Regulatory Affairs

Summary

This role provides administrative support functions to the Office of Clinical Research Initiatives, coordinates office communications and correspondence; creates and maintains regulatory documentation systems. 
This role will primarily be responsible for the daily administrative functions of the Office of Clinical Research Initiatives and oversee regulatory documentation of both data and systems for the European Union General Data Protection Regulation (GDPR) as well as FDA source documentation for Investigational New Drugs and Devices (IND/IDE).  
 

Job Duties

• Coordinate the preparation, data collection, assembly, and review of regulatory submissions for GDPR and IND/IDE programs. 
• Maintain study regulatory files and prepares and oversee study-related regulatory documentation. 
• Generate regulatory reports supporting the office of Clinical Research Initiatives. 
• Support study monitoring as required. 
• Assist with coordinating and scheduling meetings and communications. 

Minimum Qualifications

• High School diploma or GED.
• Four years of relevant experience.

Preferred Qualifications

• Public health background.
• Experience in regulatory affairs.