Robert has considerable Agency and industry experience in all phases of clinical research auditing. While at FDA, Robert inspected clinical/principal investigators, sponsor monitors and IRB’s (Institutional Review Boards).  While serving as the Supervisory Drug Investigator, Robert was responsible to assign and review all clinical research inspection reports and recommended regulatory actions where warranted.   

From 2004 through 2006 Robert worked for a full service CRO (clinical research organization), located in Cincinnati, Ohio where he served as a Senior CRA (clinical research associate) in the corporate auditing group. Robert’s responsibilities included: conducting internal and external clinical research audits and hosting drug sponsor visits.  Robert also served as the quality group representative on the SOP Task Force, responsible for reviewing/editing SOPs and SWI’s (standard work instructions) and provided regulatory guidance to the research staff. 

In 2005, Robert served as the team lead in a multi-national phase III, double-blinded, clinical research audit at several international sites. To help establish audit uniformity among the different auditors, Robert prepared an audit checklist that outlined the minimum expected coverage at each of the principle investigator sites. After completing the audits at the (9) different sites, Robert summarized the findings and presented a detailed report to the drug sponsor.