As Executive Director of US Medical Operations for AES/Synexus since May, 2022, I am responsible for managing all Investigators and Medical Staff at our 30+ wholly owned Clinical Research sites in the US. I am a member of the AES/Synexus Leadership Team with ultimate responsibility for the performance, quality, training, and hiring of Medical Staff at our Dedicated Clinical Research sites. Between 1993 and 2021, I was a Principal Investigator on over 700 Phase 2, 3, and 4 pharmaceutical and consumer clinical trials in over 70 therapeutic areas in my role as Medical Director of Radiant Research in Cincinnati. I was responsible for study conduct, staff management and leadership, study oversight, study feasibility, patient recruitment, safety and retention, business development and sponsor relations, medical partnering, strategic growth, and attending local and national meetings.As Corporate Medical Director at Radiant Research between 2010 and 2015, I acted as a liaison between Radiant Management and all Radiant physicians, interviewed and made recommendations about new Medical Directors and Principal Investigator hires, main contact person for all Radiant physicians who needed study advice, evaluated site operations to improve overall study conduct, trained new Radiant physicians in person and continuing training of all other Radiant investigators, developed investigator training modules, organized and led quarterly Medical Director calls, and was a member of Radiant's Senior Management team.I have worked with pharmaceutical companies to help develop and critique clinical trial protocols, discuss feasibility and advise on informed consent forms. In addition, I have consulted with pharmaceutical companies as a thought leader in various therapeutic areas, data integrity and ethical considerations.I have also been a non-affiliated voting Board Member with Schulman/Advarra IRB since 2013. As such, I review and present a wide range of Investigational drug and device protocols, Investigator Brochures, Amendments, and ICFs to ensure subject safety, scientific validity, risk mitigation, LAR determinations, Pediatric Subpart D analysis, etc. to discuss with the Board. As a voting Board member, I am an active participant in all IRB matters addressed during Board meetings.From 1992 to 2006, I was the Senior Medical Director of Critical Care Physician Services at 2 teaching hospitals where I managed 40+ physicians along with all the other clinical responsibilities required by the role. Expert in FDA, ICH, IRB, and local authorities regulations.