Ana Perez
Summary
Experienced Clinical Research Professional with expertise in managing clinical trials and ensuring regulatory compliance. Proficient in protocol development, data analysis, and patient safety oversight, emphasizing team collaboration and strategic planning. Known for effective problem-solving and adaptive leadership in fast-paced environments.
Overview
14
14
years of professional experience
Work History
Sr. Clinical Research Coordinator
Rady’s Children Hospital (CHOC)
09.2025 - Current
- Manage end-to-end study start-up and regulatory activities, including IRB submissions, contracts, DUAs, protocol development, and oversight of essential documents in compliance with GCP.
- Lead development of CRFs, informed consent forms, and source documents to ensure accurate, high-quality data collection.
- Provide operational leadership for study execution, overseeing CTMS and EDC builds, vendor coordination, resource planning, and data reporting.
- Ensure data integrity and quality across all study systems, maintaining inspection readiness and adherence to quality standards.
- Support execution of risk-based quality monitoring plans, identifying trends, risks, and corrective actions.
- Train and mentor study staff on trial processes, data quality, and regulatory compliance.
Clinical Research Associate II
Kaiser Permanente
07.2024 - 10.2025
- Oversaw oncology clinical trials, ensuring protocol adherence, subject safety, and compliance with ICH-GCP, IRB requirements, and applicable regulatory standards.
- Executed site monitoring and quality audits across satellite sites to verify data integrity, regulatory compliance, and adherence to study requirements.
- Led study start-up and regulatory activities, including preparation, submission, and maintenance of essential documents and Investigator Site Files.
- Advanced clinical systems and process improvements by supporting CTMS implementation, protocol digitization, data migration, and data quality optimization.
Clinical Research Coordinator
Providence Medical Foundation
04.2018 - 07.2024
- Managed Phase II–IV inpatient and outpatient clinical trials across multiple therapeutic areas, supporting study start-up, internal feasibility, and enrollment activities.
- Ensured protocol, SOP, and regulatory compliance in accordance with IRB, ICH-GCP guidelines, and federal regulations.
- Supported quality and process improvement initiatives, including SOP and source document development, compliance training, and workflow optimization.
- Collaborated with cross-functional teams providing mentorship and contributing to continuous process improvements.
Sr. Clinical Research Coordinator
Anaheim Clinical Trials
11.2012 - 04.2018
- Streamlined clinical trials from initiation to close-out across various therapeutic areas.
- Ensured compliance with IRB, ICH-GCP guidelines, and federal regulations throughout studies.
- Coordinated participant recruitment, enrollment, and execution of study protocols effectively.
- Maintained data integrity through thorough entry, query resolution, and reporting.
- Mentored research staff to elevate performance, compliance, and operational efficiency.
Education
Bachelor of Science - Public Health
California State University, Fullerton
Fullerton, CAMaster of Science - Regulatory Affairs
San Diego State University
San Diego, CA01.2027
Skills
- Clinical research ethics
- Data collection
- Protocol development
- IRB submissions; IRBNet; iRIS; Oncology Patient Enrollment Network; Clinical Trials System Unit; Shared Investigator Platform
- Data analysis
- Problem-solving and multitasking abilities
- Adaptability and flexibility
- Effective communication
- Quality assurance
- Microsoft Office Suite; Word, Excel, Outlook, PowerPoint, OneNote, Teams, SharePoint
- Clinical Trials Management System; TMF; ISF; Florence, Complion, Verily, Medidata Rave, Veeva, Oracle; REDCap; IWRS/IRT; EPIC; Cerner
- Cross-functional Team Leader, Mentor & Trainer
- Clinical Project Management; Clinical Operations Management; Risk Management
- Adverse Event, CTCAE & RECIST 11 Reporting
- Quality Assurance, Satellite Site Monitoring, CAPA Development, Audit Preparedness & Inspection Support
- Standard Operating Procedure Development; Source Document Development; Case Report Forms Development
Timeline
Sr. Clinical Research Coordinator
Rady’s Children Hospital (CHOC)
09.2025 - Current
Clinical Research Associate II
Kaiser Permanente
07.2024 - 10.2025
Clinical Research Coordinator
Providence Medical Foundation
04.2018 - 07.2024
Sr. Clinical Research Coordinator
Anaheim Clinical Trials
11.2012 - 04.2018
Master of Science - Regulatory Affairs
San Diego State University
Bachelor of Science - Public Health
California State University, Fullerton