Regulatory Affairs and TMF Specialist
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Regulatory Affairs Specialist with 6 years of experience. Specialities in diligent maintenance of electronic trial master file (eTMF), regulator audit preparation, document quality assurance and control, and study start-up. GCP, HSP, and HIPAA compliant, as well as, up-to-date on the latest ICH and FDA guidances. Background in oncology clinical trials (both drug and device studies).
Over 5 years working with document completion, maintenance, and storage. Experience with systems such as OnCore, Veeva, Florence, SIP, CTSU, and a variety of IRB managers. Incredibly thorough at quality assurance and quality control of regulatory documents.
MS - University of Florida - Microbiology and Biochemistry
BS - University of North Carolina at Asheville - Cell and Molecular Biology, Clinical Psychology
