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.
Sue received her Bachelor of Science in Nursing from the University of Nebraska Medical Center. She received her Diploma in Nursing from Bryan Memorial Hospital School of Nursing, and her Registered Nurse License from North Carolina Board of Nursing. She is also a Certified Quality Auditor (CQA), Oncology Certified Nurse (OCN), and has a Clinical Research Auditing Certification.
Overview
Quality Assurance professional with over 20 years in FDA-regulated industry, including Quality Assurance (QA), Preclinical and Clinical Research. Registered Nurse and ASQ Certified Quality Auditor experienced in conducting all types of GxP audits.