Over four years of clinical research experience, starting as a clinical research assistant and now working in study start-up site management. Worked with sites across North America that utilize both central and local IRBs. Guided sites through their study start-up process, providing study information and documentation needed to proceed through internal site reviews. Reviewed country and site-level ICFs, essential documents, and IRB approval documentation in accordance with ICH-GCP and country regulations. Presented site and country-level updates to the client during weekly calls. Managed and submitted site, country, and study-level submissions to the Central IRB prior to site distribution. Looking to expand experience into clinical study maintenance and close out.