Regulatory Information

Preparing, Writing, Filing and Managing:

• UCMC Institutional Review Board submissions and follow-up
• CHMC Institutional Review Board submissions and follow-up
• Veterans Affairs R&D submissions and follow-up
• Community Advisory Board submissions
• FDA / Investigational New Drug submissions and follow-up
• FDA documents for clinical trials

Conducting compliance audits

Tracking adverse event reports both locally and global

Insuring compliance with Good Clinical Practice Guidelines

Meeting with monitors to ensure regulatory compliance with FDA, IRB, and sponsor requirements