Title:  Regulatory Affairs Specialist

Summary

The Regulatory Affairs Specialist works to provide centralized support within the Office of Clinical Research (OCR) to multiple Principal Investigators (PIs) across the College and its affiliates. The position supports all aspects of regulatory compliance for both therapeutic drug and device trials in varying disease areas with multiple departments. The candidate will be located at McNair Campus and work alongside the Principal Investigators and research team. The ideal candidate will be self-motivated, organized and detail oriented. This is a full-time position, generally working within normal business hours of Monday-Friday, 8:00 AM - 5:00 PM. 

Job Duties

• Coordinates efforts associated with the preparation of regulatory start-up and ongoing clinical trials documents
• communicates with Central and local IRBs, CROs,Sponsors and PIs related to new protocols and protocol amendments are submitted appropriately and continuing reviews are submitted in a timely manner 
• Compiles and maintains regulatory documentation electronically and investigator site file.
• Coordinates, prepares, or reviews regulatory submissions for Central IRBs, BCM IRB and affiliates.
• Work closely with study team, research staff and PI's to ensure that all regulatory documents for research studies are up-to-date so as to streamline work and achieve mutual goals 
• Keeps the research study team and Manager informed of protocol related issues
• Facilitate communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• Coordinate and submit timely responses to CRO's,Sponsors, Central and BCM IRB, PI's inquiries
• Maintains study regulatory database, OCR regulatory database as applicable
   

Minimum Qualifications

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

Preferred Qualifications

• Bachelor’s degree in a related field.
• IRB experience
• Clinical trial experience