Sandi Bernhardt

Background

About Sandi Bernhardt

Ms. Bernhardt has over 20 years clinical research experience of increasing responsibility in contract research organizations. She currently holds responsibility for project and clinical trial management to ensure activities are conducted in accordance with the protocol, US Regulations, ICH Guidelines for Good Clinical Practices and standard operating procedures. This includes the management of resources, personnel, timelines and allocated budget. Ms. Bernhardt acts as the primary contact with Sponsors as well as a liaison between investigative site personnel, monitoring team and project vendors. Ms. Bernhardt has served as Operations Director for large international CRO Phase 1, in-patient unit. In this role she provided overall operational management in the conduct of clinical trials of all phases. Her direct supervisory experience included clinical research and medical professionals with a staff of over 20. Ms. Bernhardt is experienced in clinical monitoring of Phase 1 through 3 studies. She possesses a diverse background in nursing, surgery and clinical research with over 35 years of experience in a variety of therapeutic areas. CLINICAL RESEARCH EXPERTISE •Project Management Phase 1 through 3 Clinical Trials •Clinical Monitoring •Pharmacovigilance and Medical Safety Monitoring •Data Management and Quality Control •Phase 1: First Entry-Safety/Tolerance, Pharmacokinetic/Pharmacodynamic, Drug • Interaction, Bioequivalence/Bioavailability, Radiolabelled studies