Arnoldo Gutierres Abrica
Los Angeles,CA
Summary
Detail-oriented Clinical Research Coordinator with expertise in regulatory compliance and clinical trial management. Led multi-phase trials, ensuring adherence to ICH-GCP standards while optimizing operational efficiency. Developed training programs for junior staff and streamlined study start-up activities, improving study execution and patient recruitment.
Overview
3
3
years of professional experience
Work History
Clinical Research Coordinator
USC Keck School of Medicine
Los Angeles, California
06.2024 - Current
- Coordinated site start-up activities, ensuring timely collection and tracking of essential regulatory documents across multiple study sites
- Supported regulatory and operational activities for Phase II–III clinical trials in compliance with ICH-GCP guidelines
- Facilitated communication between sponsors, CROs, and internal study teams, enhancing collaboration to meet trial timelines
- Tracked and documented adverse events (AEs/SAEs) for timely reporting and regulatory compliance
- Assisted in maintenance and organization of Trial Master File (TMF) ensuring inspection readiness
- Assisted during monitoring visits and audits by retrieving documents and supporting query resolution
- Trained junior staff on study workflows and clinical trial systems, fostering knowledge transfer and operational consistency
Clinical Research Coordinator
Medvin
Los Angeles, CA
03.2023 - 05.2024
- Coordinated with sponsors, CROs, and vendors to support study execution
- Supported day-to-day operations of rheumatology clinical trials ensuring protocol and regulatory compliance
- Facilitated study start-up activities, ensuring feasibility assessments and site readiness preparation were completed effectively
- Assisted in IRB submissions including amendments and continuing reviews
- Developed and maintained tracking tools to enhance study organization, ensure data accuracy, and streamline reporting workflows
- Coordinated onboarding of new clinical research staff, providing training on study procedures and systems for smoother integration
Education
Bachelor of Science - Biology
California State University, Los Angeles
Los Angeles, CA05-2021
Skills
- Trial Master File (TMF) maintenance & documentation
- Clinical trial start-up & site activation support
- Regulatory submissions (IRB, amendments, continuing reviews)
- Study tracking & reporting (Excel, databases)
- Meeting coordination, agendas & minutes
- Cross-functional communication (CROs, sponsors, sites)
- ICH-GCP compliance
- Microsoft Word, Excel, PowerPoint
Languages
Spanish
Professional
Timeline
Clinical Research Coordinator
USC Keck School of Medicine
06.2024 - Current
Clinical Research Coordinator
Medvin
03.2023 - 05.2024
Bachelor of Science - Biology
California State University, Los Angeles