Gayathri Pullela

Clinical Research Coordinator @Stamford Health

Bridgeport, CT, US

Designed and maintained detailed case report forms (CRFs) and source documentation using REDCap and EPIC to ensure compliance with FDA, GCP, and ICH regulations. • Coordinated over 20 clinical trials across oncology and cardiology, ensuring subject eligibility, enrollment, and adherence to protocol-defined visit schedules. • Developed automated screening logs and scheduling trackers using Excel with advanced formulas (VLOOKUP, INDEX-MATCH, conditional formatting), reducing patient recruitment time by 35%. • Executed electronic data capture (EDC) queries in Medidata Rave and resolved 100% of outstanding discrepancies within defined sponsor timelines. • Collaborated with PI and sub-investigators to submit protocol amendments, SAE reports, and continuing review submissions via IRB systems such as IRIS and WCG Connexus. • Trained new CRCs and research assistants on protocol execution, source documentation standards, and regulatory binder management. • Conducted regular monitoring visits and audit preparations, ensuring 100% accuracy in source-to-CRF verification and regulatory documentation. • Implemented a centralized document version control system using OneDrive and SharePoint, reducing regulatory document errors by 40%. • Coordinated lab sample collection, processing, and shipment according to sponsor-specific guidelines, maintaining full chain of-custody logs for over 300 samples. • Built Power BI dashboards to track enrollment metrics and site performance KPIs, supporting data-driven decisions in weekly sponsor calls.

Sacred Heart University

Masters , Health informatics

Rajiv Gandhi University of Health Sciences

Physiotherapy, Physiotherapy