Skills
Good Clinical Practice (GCP), Good Laboratory Practice (GLP), ALCOA-C, Data Integrity, Source Data Verification (SDV), Source Data Review (SDR), Regulatory Compliance, Regulatory Inspections, Quality Assurance, Audits, Peer Reviews, Corrective and Preventive Action (CAPA) Plans
About
Clinical Research and Healthcare Quality Professional (MPH) with expertise in healthcare regulatory oversight and experience supporting Phase II and III clinical trial operations across multiple therapeutic areas, including oncology, cardiology, and pulmonology studies. Leverages experience in monitoring hospital regulatory compliance with a proven track record of success in managing complex double-blind, placebo-controlled trials while maintaining strict adherence to ICH-GCP and ALCOA-C principles. Skilled in regulatory healthcare inspections, clinical quality assurance, source document review, AE/SAE reporting, and CAPA development. Driven by a deep commitment to data integrity, protocol compliance, and study participant safety, seeking to translate extensive site-level research experience and regulatory expertise into a Clinical Research Associate role. Offering complete flexibility for travel to support trial operations (up to 80%) and open to relocation.
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