Naga Ramya Sri Narisetti
Clinical Research Coordinator @DM Clinical Research
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WORK HISTORY
Clinical Research Coordinator @DM Clinical Research
US
Manage Phase clinical trials, ensuring compliance with ICH-GCP, FDA, and institutional SOPs- Recruit, screen, and consent study participants; schedule and track visits, achieving 95%+ retention through proactive followup- Enter and validate clinical data in EDC systems (Medidata, Oracle Clinical), ensuring 100% accuracy via source-to-CRF verification- Monitor patient safety by documenting and reporting AEs/SAEs, escalating to investigators and sponsors within required timelines- Prepare and submit IRB/EC documents; maintain regulatory binder and ISF to ensure continuous audit readiness- Oversee investigational product (IP) accountability, including receipt, storage, dispensing, and reconciliation- Support site initiation, monitoring visits, and sponsor/regulatory inspections, contributing to successful audits with zero major findings- Collaborate with PIs, CROs, and sponsor representatives to drive timely study milestones and deliverables.
EDUCATION
Jawaharlal Nehru Technological University Kakinada (JNTUK)
Bachelor of Pharmacy -, Pharmacy, Pharmaceutical Sciences, and Administration
Sri Chaitanya College of Education
BIPC
University of New Haven
Masters in Public Health, Public Health
ABOUT NAGA RAMYA SRI NARISETTI
I am a Clinical Research Coordinator with a background in pharmacy and experience…
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