Clinical Research Associate

Clinical Research Associate — Vanguard Clinical Research

Raleigh, NC | June 2024 – Present

• Monitored 8 active Phase II clinical trial sites across the Southeast region, completing 48 routine monitoring visits (IMVs) using Veeva Vault Clinical to track site performance and maintain a 98% protocol adherence rate.
• Audited over 2,500 patient case report forms (CRFs) and source documents for data discrepancy reconciliation, reducing site database query backlogs by 35% using Medidata Rave.
• Prepared 4 investigational sites for FDA inspection readiness using Veeva eTMF, resolving 100% of outstanding regulatory binder queries and achieving zero critical findings during internal sponsor audits.
• Coordinated with 16 site principal investigators (PIs) and study coordinators using Clinical Trial Management Systems (CTMS) to accelerate enrollment targets, boosting overall recruitment rates by 22% over 6 months.

Clinical Trial Assistant — Apex Trial Management

Durham, NC | June 2023 – May 2024

• Managed the administrative quality control of 1,200 electronic Trial Master File (eTMF) documents using Veeva Vault, reducing missing document errors by 28% prior to study database lock.
• Reconciled clinical site investigational product (IP) accountability logs for 6 parallel protocols, identifying and correcting 14 supply discrepancies using Oracle Inform.
• Distributed safety reports and protocol amendments to 12 research sites, tracking confirmation logs via Veeva Vault to achieve 100% regulatory submission compliance within a 5-day window.

Clinical monitoring, Good Clinical Practice (GCP), ICH-GCP guidelines, FDA regulations (21 CFR), source data verification (SDV), protocol compliance, Trial Master File (TMF), eTMF management, Medidata Rave, Veeva Vault Clinical, Oracle Inform, Clinical Trial Management Systems (CTMS), patient recruitment, site relationship management

Multi-Center Oncology Trial Initiation

Role: Clinical Research Associate

Tools: Veeva Vault Clinical, Medidata Rave, CTMS

Led site initiation visits (SIVs) for 3 major investigative sites, completing IRB approvals and site activations 14 days ahead of schedule to enable patient enrollment.

eTMF Quality Cleanup Initiative

Role: Clinical Trial Assistant

Tools: Veeva Vault eTMF, MS Excel, SharePoint

Audited and reorganized 3,200 clinical trial documents, correcting 95% of document metadata classification errors and ensuring compliance ahead of a major European Medicines Agency (EMA) inspection.

• Certified Clinical Research Associate (CCRA) (2025)
• Certified Clinical Research Professional (CCRP) (2024)
• Good Clinical Practice (GCP) (2023)

• Languages: English (Native), Spanish (Professional working proficiency)
• Professional Memberships: Association of Clinical Research Professionals (ACRP) member (2024–Present)
• Availability: 2 weeks notice