Namrata Kallapalli

WORK HISTORY

EDUCATION

SKILLS

ABOUT NAMRATA KALLAPALLI

Clinical Research and Regulatory Affairs Professional with 6+ years of experience supporting global Phase clinical trials across CRO environments, including ICON plc and Labcorp Drug Development.I specialize in clinical trial start-up, regulatory submissions, and essential document management, with strong alignment to Canadian regulatory frameworks and compliance standards. Core Expertise:Health Canada & REB/IRB submissions and coordinationSite activation, feasibility, and start-up timelineseTMF/CTMS management (Veeva Vault, Medidata Rave)TMF/ISF document review aligned with ICH-GCPCross-functional collaboration with CRAs, sponsors, and investigatorsI have consistently contributed to timely site activation, audit readiness, and high-quality trial execution across therapeutic areas, including oncology, neurology, and metabolic disorders.I hold a Postgraduate Certificate in Regulatory Affairs from Conestoga College, along with GCP certification and TCPS 2 (CORE-2022), strengthening my expertise in Canadian regulatory and ethical requirements.Currently working as a Clinical Trial Assistant II at IQVIA, I am looking to grow into roles in: Regulatory Affairs Clinical Trial Start-Up Clinical Operations (Canada)I am open to connecting with professionals and organizations focused on advancing clinical research and regulatory excellence.