Higher Ed. Consulting Sr. Director
Huron Consulting Group
Tom has an extensive background working with universities, hospital systems, academic medical centers, and cancer centers to maximize research program performance, improve the overall efficiency and effectiveness of research administration, and strengthen compliance programs.
PROFESSIONAL EXPERIENCE
Tom’s project experience has focused on clinical research infrastructure development and optimization, Institutional Review Board (IRB) and human research protection program (HRPP) management and accreditation, regulatory compliance assessments, and risk evaluation and management. Prior to joining Huron, Tom served as a research scientist at a leading pharmaceutical company, working in viral vaccine research and development.
SIGNATURE ENGAGEMENTS
+ Managed a major human research protection program reorganization and process standardization effort at large federal research institution involving thirteen distinct HRPPs consolidated into a single organizational structure.
+ Led a major organizational and operational transformation effort within one of the nation’s leading cancer centers to substantially improve HRPP performance, processes, and technology.
+ Served as the project director for a consortium of universities tasked with developing the national IRB reliance network prototype to operationalize the NIH Single IRB Policy for Multi-Site Research (now known as Smart IRB).
+ Served in an interim leadership role to improve compliance, efficiency, and startup times for clinical research at an NCI-designated Comprehensive Cancer Center.
+ Managed the Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation or re-accreditation efforts at twelve universities and hospitals.
+ Developed implementation plans for three separate NCI Cancer Centers to aid them in streamlining elements of their administrative support functions related to start-up and ongoing management of clinical research.
+ Designed or re-designed centralized clinical research infrastructures at six community hospital systems and medical schools to improve system-wide standardization and address investigator support needs.
+ Conducted regulatory compliance and GCP audits of specific protocols and specific investigators at the request of both university and hospital system clients as well as the law firms that represent these institutions.
+ Directed the clinical research operations of a community hospital system, including new study initiation activities, budgeting, contract development, Medicare coverage analysis, and clinical research charge capture.
+ Assessed clinical research programs and IRB activities to identify opportunities for infrastructure and process improvement at numerous institutions. These assessments included policy and procedure review as well as extensive client interviews aimed at assessing consistency between policy and practice.
+ Developed comprehensive institutional policies and procedures on IRB administration, Data Safety Monitoring Committee (DSMC) operations, institutional feasibility and scientific review processes, budget development, research contract review, and ongoing financial management of clinical
research at a wide variety of research institutions.
EDUCATION AND CERTIFICATIONS
+ Master of Business Administration, University of Notre Dame, South Bend, Indiana
+ Master of Science, Biochemistry/Molecular Biology, New York Medical College, Valhalla, New York
+ Bachelor of Science, Biological Sciences, University of Notre Dame, South Bend, Indiana
+ Certified IRB Professional (CIP)
PROFESSIONAL ASSOCIATIONS
+ Member, Public Responsibility in Research & Medicine (PRIM&R)
PUBLICATIONS/SPEAKING ENGAGEMENTS
+ Regularly presents at national conferences and webinars on best practices in clinical research administration