Regina Henley
Fuquay-Varina
Summary
Detail-oriented and compliance-focused professional transitioning into pharmaceutical manufacturing with a strong foundation in documentation management, cross-functional coordination, and regulatory standards. Skilled in process tracking, quality documentation, and communication with project teams. Eager to contribute to efficient, GMP-compliant production operations as a QA Associate, Document Control.
Overview
18
18
years of professional experience
Work History
Study Start Up Associate I
ICON PLC
11.2024 - 04.2025
- Entered and updated study start-up data in tracking systems to maintain real-time visibility for the project team, ensuring accuracy and transparency in SSU timelines.
- Coordinated distribution of confidentiality agreements and site questionnaires to support feasibility assessments and site selection, streamlining early trial operations.
- Maintained weekly communication with 45 clinical sites to follow up on essential document submissions, accelerating site readiness for study participation.
- Reviewed and negotiated Informed Consent Forms and Confidentiality Disclosure Agreements under SSU Lead guidance, contributing to timely contract finalization.
- Delivered weekly site activity updates to SSU Leads, promoting proactive issue resolution and maintaining study momentum.
Senior Project Specialist
Syneos Health (formerly Inventiv Health/INC Research)
05.2018 - 08.2024
- Supported CNS and Oncology studies by managing clinical operations and administrative tasks, contributing to on-time study milestones.
- Executed project team tasks such as tracking action items in the Project Delivery Center and routing documents for client signatures, enhancing project workflow.
- Coordinated logistics for team meetings, prepared agendas, and documented meeting minutes, fostering alignment between internal teams and sponsors.
- Updated SOP tracking for both internal and sponsor documents, ensuring protocol adherence and regulatory compliance.
- Managed eTMF processes by uploading, indexing, and quality checking documents, achieving 100% TMF query completion for audit readiness.
- Acted as primary TMF contact during client meetings.
- Handled user access for EDC and vendor systems using project platforms, expediting onboarding and minimizing workflow disruptions.
- Analyzed TMF completeness reports, resolved discrepancies, and facilitated document reconciliation to maintain high-quality documentation.
Project Coordinator/Senior Project Coordinator
InVentiv Health
05.2011 - 05.2018
- Organized study operations by managing meeting logistics, clinical supply shipments, and site communications, contributing to efficient project execution.
- Resolved system access and technical issues to ensure uninterrupted access to databases and project systems for study teams.
- Performed detailed QC of trial documentation, maintaining 100% compliance with TMF standards and regulatory expectations.
- Reviewed CTAs and processed site and IRB invoices, supporting financial management and contract oversight.
- Conducted final quality checks on central files, identifying and documenting missing content for site monitors to collect.
- Maintained comprehensive tracking spreadsheets for enrollment, regulatory documents, site contacts, and training logs, ensuring data accuracy and project visibility.
Clinical Data Associate II
PPD
02.2008 - 01.2011
- Conducted systematic reviews of clinical data listings and implemented discrepancy management protocols, improving database integrity and reducing errors.
- Executed data queries and managed correction processes to ensure timely resolution of inconsistencies, enhancing overall data quality.
- Oversaw weekly distribution of data correction forms to internal stakeholders, maintaining continuous study progress.
Product Safety Administrator I
PPD
12.2006 - 02.2008
- Logged and processed adverse events in Argus Safety following Medical Information team intake, ensuring timely case distribution to Safety Specialists.
- Improved pharmacovigilance operations by streamlining case intake workflows, increasing departmental efficiency and compliance.
Education
Certificate - BioWork
Wake Technical Community College
Raleigh, NC08-2025
Bachelor of Science - Communication
East Carolina University
Greenville, NC05-2011
Bachelor of Arts - Liberal Studies
University of North Carolina At Greensboro
Greensboro, NC12-2008
Skills
- Desire to Learn
- Work Ethic
- Teamwork
- Veeva Vault
- SharePoint
- Time Management
- Trial Master File
- Microsoft Teams
- Team Collaboration
- Microsoft Office
- Good Clinical Practice (GCP)
- Attention to Detail
- Flexibility
- Organization
- Effective Communication
- Standard Operating Procedures (SOPs)
- Good Documentation Practices
Timeline
Study Start Up Associate I
ICON PLC
11.2024 - 04.2025
Senior Project Specialist
Syneos Health (formerly Inventiv Health/INC Research)
05.2018 - 08.2024
Project Coordinator/Senior Project Coordinator
InVentiv Health
05.2011 - 05.2018
Clinical Data Associate II
PPD
02.2008 - 01.2011
Product Safety Administrator I
PPD
12.2006 - 02.2008
Certificate - BioWork
Wake Technical Community College
Bachelor of Science - Communication
East Carolina University
Bachelor of Arts - Liberal Studies
University of North Carolina At Greensboro
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