Anusha Aduri

• Managed site regulatory documentation, including ethics/IRB submissions, approvals, and ongoing compliance, ensuring adherence to ICH-GCP guidelines and sponsor requirements.
• Prepared and maintained site master files, delegation logs, and essential study documents to support audits and inspections.
• Coordinated with sponsors, monitors, and internal teams to ensure timely submission of trial data and regulatory updates.
• Oversaw adverse event (AE/SAE) reporting and protocol deviations, maintaining compliance with ethical and regulatory standards.
• Assisted in study start-up activities, including preparation of regulatory packages for ethics committees and site files.
• Collaborated with cross-functional teams (laboratory, pharmacy, and clinical staff) to ensure accurate data collection, documentation, and trial compliance.
• Demonstrated strong attention to detail, organizational skills, and compliance awareness, essential for regulatory affairs operations.

Key Achievements / Highlights:

• Maintained 100% audit readiness with zero major findings during sponsor monitoring visits.
• Gained practical exposure to international regulatory requirements and cross-border clinical trial processes.