Over fifteen years experience in conduct and management of Human Research activities at the investigator, department and institutional level as well as administrative oversight and organizational design responsibilities including staff hiring, training and supervision, workflow design, organizational structure and collaboration with database designers to customize databases to the work environment. Experienced in reviewing, presenting and providing training on regulatory criteria for the conduct of human subject research. Experienced in research program management to support successful long-term government funded research and pharmaceutical industry sponsored research, responsibilities have included the development of educational tools and presentations relating to budgeting, contracting compliance and good clinical practice. Related follow up responsibilities include experience in internal monitoring/auditing of protocols and related records and facilitating communications and negotiating between hospitals, investigators and sponsors.