Minh Nguyen
Fountain Valley
Summary
Detail-oriented Clinical Study Associate specializing in document review, filing, and quality control to uphold Trial Master File integrity and regulatory compliance. Conducts quality checks and reconciles TMF contents against essential document lists while implementing corrective actions. Collaborates with cross-functional teams to address documentation issues, support audits, and ensure ongoing study readiness.
Overview
4
4
years of professional experience
Work History
Clinical Study Associate
Johnson & Johnson, Medical Devices
Irvine, California
07.2024 - Current
- Managed study start-up activities, including ICF review and revision for regulatory compliance; developed essential document lists and tracked TMF build-out progress to facilitate timely study initiation.
- Identified and resolved documentation discrepancies using protocol and GCP expertise; implemented corrective actions and process changes to enhance documentation integrity across study phases.
- Conducted in-house and site documentation reviews, supporting internal and competent-authority audits to ensure TMF completeness and adherence to GDP and SOPs.
- Collaborated with cross‑functional teams (clinical data management, field/monitoring teams) to manage queries, reconcile data issues, and expedite resolution for accurate study records.
Clinical Research Coordinator
CenExel Clinical Research
Garden Grove, California
03.2022 - 07.2024
- Coordinated patient enrollment for clinical trials, achieving protocol compliance and enhancing participant engagement.
- Managed regulatory documentation for trial submissions and approvals, facilitating timely regulatory review.
- Monitored participant safety and reported adverse events per regulatory guidelines.
- Conducted site visits to ensure adherence to study protocols and participant welfare.
- Maintained accurate study records in electronic data capture systems, ensuring readiness for audits and regulatory inspections.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results.
Education
Bachelor of Arts - Human Physiology
University of Minnesota
Minneapolis, MN06-2020
Skills
- Trial management
- Documentation review
- Electronic data capture
- Audit preparation
- Document management
- Microsoft office
- Cross-functional teamwork
- Verbal communication
Timeline
Clinical Study Associate
Johnson & Johnson, Medical Devices
07.2024 - Current
Clinical Research Coordinator
CenExel Clinical Research
03.2022 - 07.2024
Bachelor of Arts - Human Physiology
University of Minnesota