Experience

Twenty years across sponsor, CRO, site, and central IRB functions.

Feb 2024 – Present

Executive IRB Chair

Univo IRB - AAHRPP-Accredited Commercial Central IRB

Executive leadership across all IRB committee operations, reviewer governance, meeting management, and regulatory review within a PE-backed commercial central IRB supporting FDA-regulated and Common Rule research across drug, biologic, and medical device programs. Functional Owner of Board Service Delivery - accountable for board governance, reviewer infrastructure, KPI development, and Management System participation. 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. Performs full-board, expedited, exempt, and chair reviews; serves as liaison between the committee and sponsors on IRB requirements and determinations.

2017 – 2023

Non-Affiliated Scientific Board Member

Advarra IRB - Commercial Central IRB

Six years as a non-affiliated scientific board member at one of the largest commercial central IRBs in the United States. Reviewed drug, biologic, and device studies across full board, expedited, and exempt pathways; evaluated informed consent, investigator brochures, advertising, and product information for regulatory compliance and subject protection adequacy.

Jul 2020 – May 2023

Associate Director of Clinical Operations

AriBio USA - Clinical Research Consultant

Executive-level sponsor clinical operations for FDA-regulated investigational products across the R&D pipeline. Led Phase 3 CRO qualification including RFP generation, bid defense, vendor selection, and IND Transfer of Regulatory Obligations (21 CFR 312.52). Directed vendor negotiations across CROs, laboratory service providers, drug packaging and storage vendors, and eCOA/ePRO platforms. Led weekly CRO and vendor oversight calls on behalf of the sponsor.

2008 – 2023

Principal & Clinical Research Consultant

Glenwood Clinical Monitoring, Inc.

Fifteen years of independent clinical research consulting, monitoring, and operational strategy across Phase 1–3 programs. Supported study startup including RFP development, CRO selection, bid defense, site qualification, budget and CTA review, and investigator engagement. Provided protocol compliance, regulatory adherence, AE/SAE documentation, investigational product accountability, TMF management, and data query resolution across complex multi-site clinical programs.

Jul 2004 – Sep 2008

Senior Regional Clinical Research Associate

PPD, Inc.

Comprehensive clinical monitoring across up to twelve investigative sites in accordance with ICH GCP and 21 CFR Parts 50, 54, 56, and 312. Conducted site evaluation, initiation, interim, and closeout visits; prepared detailed monitoring reports; managed protocol deviation tracking, investigator file audits, and drug accountability. Mentored junior monitors and completed CRA trainer certification.

2003 – 2004

Biotech / Pharmaceutical Associate

Nova Factor Biotech-Pharmaceutical Services

Early biotech and pharmaceutical services experience preceding transition to global CRO monitoring.

1999 – 2004

Registered Nursing Practice

Neonatal Critical Care, Pediatric & Emergency Settings

Prior clinical and healthcare operations experience spanning neonatal critical care, emergency nursing, pediatric care coordination, regional clinical operations, and biopharmaceutical support.

Core Areas of Expertise

Domains of active practice.

Full-board, expedited, exempt & chair IRB review
IRB stipulation & deferral response strategy
AAHRPP accreditation & compliance alignment
FDA BIMO inspection readiness & 483 response
IND / IDE / BLA / NDA / 510(k) / De Novo / HDE / PMA pathways
CRO qualification, bid defense & TORO
Vendor oversight & quality agreements
Informed consent architecture (21 CFR Part 50)
Vulnerable populations (21 CFR Part 50 Subpart D)
Belmont Report, Common Rule, HIPAA, GDPR & TCPS2
Unanticipated problems, PREs & 21 CFR 312.32 reporting
Reviewer recruitment, credentialing & scalability
Education, Certifications & Affiliations
  • -Fellowship in Bioethics - Harvard Medical School Center for Bioethics
  • -MBA - University of North Carolina Wilmington
  • -MS Clinical Research Organization & Management - Drexel University College of Medicine
  • -BSN - Western Carolina University
  • -Registered Nurse - NC License #161931, Multi-State Privileges
  • -ACRP Certified Project Manager (CPM)
  • -ACRP Certified Medical Device Professional (CMDP)
  • -ACRP Certified Clinical Research Associate (CCRA)
  • -ICH E6(R3) Good Clinical Practice
  • -Health Canada / TCPS2 & PIPEDA
  • -Member, Association of Clinical Research Professionals (ACRP) - since 2009
  • -Member, PRIM&R - since 2023

Curious whether this executive-level advisory support is the right fit for a specific protocol, program, or IRB challenge?

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