Elizabeth Lee Williams
Wendell,NC
Summary
Clinical research professional with over 20 years of experience in managing global phase I-IV trials. Expertise in trial master file management and maintaining inspection readiness, resulting in improved regulatory compliance and study quality. Strong collaboration with stakeholders facilitates efficient study execution and adherence to industry standards.
Overview
28
28
years of professional experience
Work History
Clinical Trial Associate | Clinical Support Specialist | Senior Clinical Trial Assistant | Clinical Trial Assistant
UCB
06.2004 - Current
- Manage Trial Master Files throughout the clinical trial lifecycle, ensuring complete, inspection-ready documentation for global Phase I–IV studies.
- Drove process improvements that enhanced TMF quality and ensured inspection readiness.
- Performed quality reviews of regulatory and essential documents, collaborating with CROs and study teams to address documentation deficiencies.
- Serve as Subject Matter Expert for informed consent documentation, coordinating review, approval, version control, distribution, and compliance across multiple clinical studies.
- Lead annual Financial Disclosure activities, preparing FDA Forms 3454 and 3455 while supporting BIMO documentation and regulatory submissions.
- Maintain Clinical Trial Management System (CTMS) data and ensure accuracy of study records through ongoing quality control and issue resolution.
- Support investigator documentation, IRB records, curriculum vitae collection, study essential documents, and regulatory files.
- Prepare studies for sponsor audits, regulatory inspections, and monitoring activities by ensuring documentation completeness and compliance.
- Collaborate with Clinical Project Managers, Quality Assurance, investigators, CROs, and vendors to maintain study timelines and regulatory compliance.
- Coordinated operational activities such as study access, vendor management, financial reporting, meeting logistics, study archiving, and invoice reconciliation to streamline processes.
Clinical Support Specialist
ClinForce / GlaxoSmithKline
04.2004 - 06.2004
- Supported international Phase III–IV clinical trials through coordination of regulatory documentation and study operations.
- Coordinated with clinical sites, vendors, and project teams to ensure timely achievement of study milestones and maintain project timelines.
- Prepared investigator site initiation documentation and maintained regulatory binders to ensure compliance and facilitate smooth site activation.
- Conducted quality reviews of informed consent and regulatory documentation to uphold ICH-GCP standards and protect participant rights.
- Supported investigational product documentation, investigator tracking, and study communications.
Clinical Operations – HIV
GlaxoSmithKline
04.2003 - 04.2004
- Supported multinational HIV clinical trials across the United States, Latin America, and the United Kingdom.
- Managed regulatory documentation, study drug accountability, and inventory tracking to ensure operational compliance.
- Coordinated communications among investigators, vendors, and clinical project teams to facilitate smooth project execution.
- Assisted with study budgets and vendor payments while maintaining project timelines and database integrity.
Clinical Support Specialist – Investigator Initiated Studies (Medical Affairs – Psychiatry)
GlaxoSmithKline
01.2000 - 04.2003
- Coordinated investigator-initiated clinical studies from startup through closeout, ensuring compliance with regulatory standards and study protocols.
- Managed Research Support Agreements, financial disclosures, and investigator payments, facilitating timely regulatory documentation for NDA submissions.
- Coordinated study supplies, protocol documentation, and clinical study reports, enhancing publication tracking and overall study efficiency.
- Prepared meeting materials, maintained study documentation, and trained staff on study procedures.
Senior Administrative Assistant – Case Report Form Design & Development
Glaxo Wellcome (ACC Staffing)
05.1998 - 01.2000
- Facilitated Case Report Form design and managed documentation for clinical studies, ensuring compliance and accuracy.
- Coordinated executive calendars and international meetings, optimizing travel arrangements and streamlining department operations.
- Delivered comprehensive administrative support to clinical development leadership, ensuring precise documentation and efficient record management.
Education
Bachelor of Arts - Business Administration
Peace College
Skills
- Clinical trial coordination
- Regulatory affairs and IRB documentation
- Trial master file management
- Clinical trial monitoring
- Inspection readiness and audit preparation
- Clinical trial management systems
- Good clinical practice compliance
- FDA regulatory compliance
- Financial disclosure management
- Investigator and site support
- Essential regulatory documents
- Quality assurance and control
- Cross-functional collaboration
- Clinical data management
- SOP compliance
- SharePoint proficiency
- Microsoft Teams expertise
- Microsoft Office suite proficiency
- Veeva eTMF management
- Documentum experience
Professional Highlights
- More than 20 years supporting global Phase I–IV clinical trials.
- Extensive experience preparing studies for audits, inspections, and monitoring visits.
- Subject Matter Expert for informed consent documentation and Financial Disclosure compliance.
- Experienced supporting FDA submissions, regulatory documentation, and essential clinical trial records.
- Proven ability to manage multiple concurrent studies while maintaining regulatory compliance and inspection readiness.
- Strong collaborator with investigators, sponsors, CROs, Clinical Project Managers, and Quality Assurance teams.
Timeline
Clinical Trial Associate | Clinical Support Specialist | Senior Clinical Trial Assistant | Clinical Trial Assistant
UCB
06.2004 - Current
Clinical Support Specialist
ClinForce / GlaxoSmithKline
04.2004 - 06.2004
Clinical Operations – HIV
GlaxoSmithKline
04.2003 - 04.2004
Clinical Support Specialist – Investigator Initiated Studies (Medical Affairs – Psychiatry)
GlaxoSmithKline
01.2000 - 04.2003
Senior Administrative Assistant – Case Report Form Design & Development
Glaxo Wellcome (ACC Staffing)
05.1998 - 01.2000
Bachelor of Arts - Business Administration
Peace College