Sai Likhitha Uppala

Clinical Research Coordinator @Parexel

US

Streamline trial operations by leading participant outreach, informed consent discussions, and visit scheduling, resulting in a 15% increase in recruitment and retention while safeguarding adherence to ICH-GCP, FDA, and HIPAA standards.• Enhance data accuracy by validating entries in REDCap and Medidata, proactively resolving data queries and implementing quality checks that cut discrepancies by 20%.• Partner with investigators and regulatory teams to prepare IRB submissions, protocol amendments, and TMF updates, ensuring 100% timely approvals and continuous compliance.• Safeguard audit readiness by organizing CRFs, informed consent forms, and regulatory binders, contributed to an internal monitoring visit with zero findings, reinforcing site credibility.• Monitor patient safety and escalate adverse events through SOP-driven reporting workflows, supporting risk management and compliance with EMA and FDA requirements.• Collaborate across disciplines with physicians, nurses, and research staff to optimize workflow, cutting scheduling and protocol check turnaround by 25%.

Acharya Nagarjuna University

Doctor of Pharmacy, Pharmacy

University of North Texas

Masters, Health Data Analytics

Chalapathi Institute of Pharmaceutical Sciences, Lam

Doctor of Pharmacy - PharmD, Pharmacology