MCRA
Sue is a Senior leader in clinical research, quality assurance, and regulatory compliance. She is proficient in domestic and international audits (routine, directed and for cause) of clinical trials (Phases I-IV) at investigator sites, early phase units, IRBs, contract research organizations (CROs), service providers, as well as in the conduct of internal process audits. Sue is also skilled in the development, coordination, and implementation of Training/Curriculum, Inspection Readiness activities, including on-site and remote trainings. She has expertise in Research Committee Management/Data Safety Monitoring and QA facilitation and support during regulatory inspections.
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MCRA
MCRA is a leading advisory firm and Clinical Research Organization (CRO) to medical technology developers. Core areas of expertise include regulatory, reimbursement, clinical research, healthcare compliance and quality assurance.