Michelle Coughlin, Manager, Medical and Regulatory Writing, brings 20+ years of experience in US and global clinical research and regulatory oversight of clinical research to her role at Premier. As former vice chair of a large North American IRB, Michelle has significant expertise in medical ethics and human subject protection. Michelle is knowledgeable in both drug and device regulations and has special interest in pediatric and rare disease research. Michelle has a MS in medical genetics from the University of Cincinnati.