Harshal Wadkar

I’m a GCP-certified Clinical Research Coordinator with ~3 years of experience across Phase I–IV clinical trials. I focus on data quality and compliance through site monitoring support, EDC query resolution, and audit-ready documentation.

In my roles, I’ve coordinated patient visits (screening, enrollment, follow-ups), supported feasibility and site selection, and handled AE/SAE cases with proper documentation and reporting timelines. I also maintain ISF and regulatory files to stay inspection-ready.

I work effectively with sponsors, CROs, and investigators to ensure protocol compliance and ICH-GCP alignment, using a strong understanding of ALCOA+ principles, SAE reporting, and clinical trial lifecycle management.