Julie Choudhury

Julie is a Clinical Research Professional with more than 10 years of experience in the clinical trial industry, working on both IDE and IND Clinical Research trials. Her expertise lies in study design and managing/conducting clinical trials, protocol writing, site start-up/management/close-out, clinical document review, regulatory management, and study reporting.  She has also been instrumental in grant-writing, CTA’s, government contacts/BIDS, CERs, SSCP, 510K submissions, PMS, FDA Submissions (NDA/ANDA/IND/IDE/EUA) and De Novo requests. 

Julie possesses a working knowledge of FDA regulations, ICH guidelines, requirements for cGMP, Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulations and compliance as they relate to clinical trial documentation and regulatory submissions, including completing TMF’s.  She holds a Master of Public Health (MPH) degree focused on Health and Human Behavior and Promotion from Keck School of Medicine of the University of Southern California (USC).