Elizabeth Ronk Nelson, MPH, has more than 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a Clinical Research Program Coordinator and Researcher and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer and Compliance Director.
Her professional areas of specialization include fraud detection and deterrence; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventative action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; Sponsor/CRO, Clinical Investigator site, and IRB development and quality improvement (QI) plans; contractual obligation evaluations; vendor audits/assessments; and site selection/qualification assessments.
EVENTS & ACTIVITIES (Speaking, Spoken, and Authored)