Shraddha S Mhatre

About Shraddha S Mhatre

I’m a Clinical Research Professional with 6+ years of experience supporting global clinical trials across all study phases, with a strong foundation in clinical operations, site coordination, and regulatory compliance.At IQVIA, I worked closely with investigative sites and cross-functional teams to support site initiation, ongoing trial execution, and study close-out. My role involved maintaining accurate trial documentation, supporting TMF and eTMF processes, ensuring adherence to ICH-GCP and SOP requirements, and resolving site-level operational issues to keep studies on track.A significant part of my experience includes supporting investigator payments and reimbursements, coordinating with internal teams to address compliance and process gaps, and working across multiple clinical trial systems, including CTMS, EDC, IVRS, and IRT. This background has given me a strong understanding of site management, trial workflows, and the day-to-day operational responsibilities essential to Clinical Research Associate (CRA) and Clinical Trials Associate (CTA) roles.Contact: s••••••••@gmail.com

Experience

1. Graduate Research Assistant

   Boston Medical Center (BMC)

   Jan 2025 — Present · Boston, MA, US

   Supported dermatology research studies by assisting with protocol development and IRB submissions for secondary data use. • Ensured compliance with regulatory, privacy, and ethical standards throughout the research process. • Conducted data extraction, cleaning, and organization from EHR sources, facilitating preliminary statistical analyses. • Contributed to study documentation and prepared materials for presentations and publications.

Education

• Boston University School of Medicine

  Master's degree, Clinical Research

• University of Mumbai

  Bachelor of Science - BS, Biotechnology

• University of Mumbai

  Master of Science - MS, Biotechnology