Gretchen Miller Bowker, MS, RAC, FRAPS – Chief Operating Officer and Co-Founder

Gretchen Miller Bowker, MS, RAC – Chief Operating Officer and Co-Founder

Gretchen Miller Bowker, MS, RAC, FRAPS – Chief Operating Officer and Co-Founder

Gretchen Miller Bowker serves as Chief Operating Officer for Pearl IRB and has over 25 years experience in the development of drugs, biologics and devices.  She is a recognized leader in regulatory, bioethics, and compliance. She has extensive experience in working within institutions, large pharmaceutical companies, small biotechs, and large device companies.   Gretchen spent over 15 years of her career in large sponsor company environments working at both Eli Lilly and Roche Diagnostics (formerly Boehringer Mannheim).  She also has real world small start up experience having led all quality efforts including the clinical plan at a small biotech.  Throughout her career, she has successfully assembled teams of experts, developed processes and procedures, driven organizational growth, and implemented strategic plans, which ensured successful clinical development of drug, device and diagnostic products.

Prior to co-founding Pearl IRB, Gretchen served as Director of Regulatory and Compliance Service Delivery at Safis Solutions where she served institutions, sponsors, and CROs.  Prior to joining Safis, she built a successful regulatory and compliance team at a start up company.  Gretchen is an experienced team leader with specific expertise in meeting global regulatory body expectations, clinical development, and regulatory compliance.

At Pearl IRB, Gretchen oversees the company’s IRB review services, and serves as the company’s Quality Director.

Gretchen has lent her talents as a guest speaker on quality and regulatory topics for Indiana University, Purdue University and multiple national healthcare and pharmaceutical conferences, and is the current Chair of the Indiana Chapter of RAPS. She has held the position of Adjunct Professor of Clinical Research and Regulatory at The George Washington Medical School. She also serves as the Chair of the Indiana RAPS Chapter and is on the Indiana Health Industry Forum’s Clinical Trials Alliance. Gretchen earned an M.S. in Biology from Purdue University, a B.S. in Biology from Indiana University, and has been RAC certified since 2002 and a RAPS fellow since 2011.