Iyonna Couvertier Clinical Research
Regulatory Affairs Coordinator Ii @Massachusetts General Hospital
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WORK HISTORY
Regulatory Affairs Coordinator Ii @Massachusetts General Hospital
EDUCATION
Suffolk University
Bachelors of Science, Biology {Health Concentration}, Chemistry Minor
Massachusetts College of Pharmacy and Health Sciences
Master of Science - MS, Clinical Research
ABOUT IYONNA COUVERTIER CLINICAL RESEARCH
Strategic Clinical Research professional offering a rare combination of site-level operational mastery and rigorous monitoring oversight to drive high performance trial execution. Specialized expertise in Phase Gastrointestinal Oncology and complex protocol requirements and ICH-GCP/FDA regulatory landscapes. Prepared to elevate project outcomes through a consistent 95% first-pass query resolution rate and the application of ALCOA+ principles to maintain superior data integrity. Proven ability to secure continuous audit-readiness through the systematic reconciliation of eTMF/ documentation and expert execution of remote and onsite Source Data Review (SDR). Complemented by 5 years of prior business leadership to effectively manage site-level budgets, timelines, and cross-functional stakeholder communications.Expert in ICH-GCP guidelines and FDA regulations (21 CFR Part 11, 312, 812). Streamlined regulatory and operational workflows leveraging mastery of essential CTMS and EDC systems, including EPIC, IRIS, NRG, CTSU, and Veeva Vault. Proficient in eTMF management, Clinical Data Review, Protocol Deviation Prevention and Protocol Deviation Review. Managed comprehensive source documentation verification (SDV) for 80+ clinical trial participants, and Source Data Review (SDR) processes to ensure data integrity and compliance with ALCOA+ and GCP principles.Leveraged scientific acumen to critically review complex pathology reports, radiologic scan review narratives, ensuring accurate eligibility screening and data interpretation for precision trials. Trained and mentored junior staff on SOP adherence, regulatory documentation, and utilization of eTMF/EDC systems.My combined academic background in Clinical Research, Biochemistry, Cancer Biology, and Molecular Genetics provides a strong scientific and multifaceted foundation for trial management, monitoring, and optimization. My oncology expertise spans Radiation and Gastrointestinal Oncology, alongside hands on wet lab experience in NK cell and multiple myeloma culture, breast and prostate cancer models, CRISPR genome editing, and 3D organoid culture.I am always open to a coffee chat! Let\'s (Here is a link to learn how to pronounce my name correctly)
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