Executive IRB Chair and clinical research operations leader with more than two decades across sponsor, CRO, site, and central IRB functions.

Executive IRB Chair, Univo IRB

Executive leadership across all IRB committee operations, reviewer governance, meeting management, and regulatory review within a commercial, AAHRPP-accredited, PE-backed central IRB supporting FDA-regulated and Common Rule research across drug, biologic, and medical device programs. Functional Owner of Board Service Delivery. Experienced in FDA inspection readiness activities resulting in inspection closure without findings, and represents the organization in FDA inspections, AAHRPP site visits, and sponsor audits.

Non-Affiliated Scientific Board Member, Advarra IRB

Six years as a non-affiliated scientific board member at one of the largest commercial central IRBs in the United States, reviewing drug, biologic, and device studies across full board, expedited, and exempt pathways.

Associate Director of Clinical Operations, AriBio USA

Sponsor-side executive clinical operations leadership for FDA-regulated investigational products. Led Phase 3 CRO qualification, RFP development, bid defense, and IND Transfer of Regulatory Obligations (21 CFR 312.52). Directed vendor governance across CROs, labs, drug packaging, and eCOA/ePRO platforms.

Glenwood Clinical Monitoring, Inc.

Fifteen years of independent clinical research consulting, monitoring, and operational strategy across Phase 1–3 programs. Supported RFP development, CRO selection, bid defense, site qualification, budget and CTA review, investigator engagement, AE/SAE documentation, IP accountability, and TMF management.

Senior Regional CRA, PPD, Inc.

Monitored up to twelve investigative sites under ICH GCP and 21 CFR Parts 50, 54, 56, and 312. Conducted site evaluation, initiation, interim, and closeout visits; mentored junior monitors and completed CRA trainer certification.

Bioethics Fellow, Harvard Medical School Center for Bioethics

Advanced fellowship in research ethics, human subject protections, emerging biomedical ethics, and regulatory oversight.

Registered Nursing Background

Prior clinical practice in neonatal critical care, pediatric coordination, and emergency nursing - grounding advisory work in direct patient-safety experience.