Julie has over 30 years of experience in basic sciences and clinical research with both academic and the pharmaceutical industry. She has an extensive background in Institutional Review Board activities with both the University of Cincinnati IRB as the IRB Director and Chair for the Social and Behavioral IRB. She has worked with Schulman IRB. She has worked with both industry, academics and government agencies to train and guide research investigators on Good Clinical Practice in pharmaceuticals, medical devices and human participant protections.
Julie received both her undergraduate degrees in microbiology and nursing from the University of Florida. She received her Master’s degree in Public Health from the University of South Florida in epidemiology and biostatistics. Her epidemiology coursework continued at the Johns Hopkins School of Public Health. She received her Regulatory Affairs Certification (RAC) in 2015. Julie is a member of Regulatory Affairs Professional Society (RAPS), Drug Information Association (DIA), Public Responsibility in Medical Research (PRIM&R), Association for Clinical Research Professionals (ACRP) and has remained a member of the Greater Cincinnati Health Council Consortium of Institutional Review Boards since 2009.
Ramachandra (Ram) G. Naik, M.D.
Biostatistics
Regulatory Science & Innovation; Biomedical Advanced R&D
EU Regulatory
Clinical Operations/Project Management
Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.
Health Policy Development
CMC, Formulation/Process Development & Sourcing
Medical Device
Eric Kolb
Melissa Thompson
QA/QC
Medical Writing/Electronic Submissions
Kristi Hultberg, B.S.
Botanicals
Government Relations and Public Affairs
Defense & National Security Practice
Commercialization and Business & Corporate Strategy
Kinexum Associates
Elijah Abass