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As Compliance Coordinator, Carilyn Garcia is responsible for quality assurance processes and systems for RxTrials' network of investigative sites. She documents standard operating procedures (SOP) for sites and ensures compliance, guaranteeing that all sites are in audit-ready status at all times. She also provides and documents education of all research staff to demonstrate their SOP education and knowledge, and conducts ongoing education for all research staff pertaining to Good Clinical Practice.
Carilyn joined the staff of RxTrials in 2010. With an extensive background in managing studies and supervising and training research staff, her past professional experience includes management and QA/QC positions at the National Institutes of Health, Food and Drug Administration's Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition. Carilyn also has worked with Covance Laboratories, Orlando Clinical Research Center and BioReliance. Her areas of expertise include implementing GCPs, GLPs, Privacy regulations, ICH Guidelines and ISO for laboratories and clinical research.
A member of the Regulatory Affairs Professional Society, Carilyn graduated from University of Puerto Rico with a BA degree in psychology and a minor in biology.