With over 30 years of experience, Ms. Edwards has a proven track record in leading and executing clinical studies and trials for diagnostic devices and IVDs leading to FDA 510(k) and de novo 510(k) clearance, PMA product approvals, and CLIA waivers. She has successfully led several clinical operations departments, and authored and executed studies across rapidly evolving disease areas, including cardiovascular, diabetes, nephrology, toxicology, oncology, women’s health, and infectious diseases. She is passionate about developing clinical trial strategies, protocol design and development, efficient clinical operations oversight and streamlined clinical trial management. Ms. Edwards has held positions at Biosite Diagnostics, Alere, Beaufort CRO, Mainz Biomed, and Karius. Ms. Edwards has a bachelor’s degree in psychology, with minors in chemistry and biology from the University of California, San Diego. Ms. Edwards is a certified Clinical Research Associate (ACRP) per the Academy’s FDA CRA Exam Committee and also has Regulatory Affairs Certification (RAC) from RAPs.
With over 30 years of experience, Ms. Edwards has a proven track record in leading and executing clinical studies and trials for diagnostic devices and IVDs leading to FDA 510(k) and de novo 510(k) clearance, PMA product approvals, and CLIA waivers. She has successfully led several clinical operations departments, and authored and executed studies across rapidly evolving disease areas, including cardiovascular, diabetes, nephrology, toxicology, oncology, women’s health, and infectious diseases. She is passionate about developing clinical trial strategies, protocol design and development, efficient clinical operations oversight and streamlined clinical trial management. Ms. Edwards has held positions at Biosite Diagnostics, Alere, Beaufort CRO, Mainz Biomed, and Karius. Ms. Edwards has a bachelor’s degree in psychology, with minors in chemistry and biology from the University of California, San Diego. Ms. Edwards is a certified Clinical Research Associate (ACRP) per the Academy’s FDA CRA Exam Committee and also has Regulatory Affairs Certification (RAC) from RAPs.