Simon Gomez
Miami,FL
Summary
Clinical Research Consultant, Lead GCP Auditor, and QA/Regulatory Specialist with 7+ years of experience supporting Phase I–IV clinical trials. Expert in ICH-GCP, FDA 21 CFR, ALCOA+ data integrity, internal audits, CAPA development, inspection readiness, and regulatory compliance. Proven leader in building Quality Assurance programs, conducting protocol compliance audits, developing SOPs, training investigators and staff, and improving site inspection performance. Hands-on background in clinical operations including patient visits, phlebotomy, data entry, and source documentation.
Overview
2026
2026
years of professional experience
1
1
Certification
Work History
Founder / Director of Quality Assurance
Modeli Research Consultants
Miami, FL
06.2023 - Current
- Serve as Lead GCP Auditor for Phase I–IV clinical research sites, conducting comprehensive internal audits aligned with ICH-GCP, FDA 21 CFR, ALCOA+, and sponsor/CRO expectations.
- Perform protocol compliance audits covering informed consent, eligibility, safety reporting, source documentation, investigational product accountability, and regulatory binders.
- Lead FDA inspection readiness programs, including mock audits, gap analyses, and corrective action planning.
- Develop and implement Corrective and Preventive Action (CAPA) plans addressing audit findings, protocol deviations, and regulatory deficiencies.
- Draft and review formal audit response letters, FDA 483 responses, sponsor/CRO responses, and regulatory correspondence.
- Provide regulatory consulting services including FDA 1572 management, CVs, medical licenses, delegation logs, training logs, SOP development, and essential document compliance.
- Design and deliver PI Oversight and GCP Training Programs covering subject safety, adverse event reporting, protocol adherence, data integrity, audit conduct, and regulatory responsibilities.
- Train site personnel on GCP, ALCOA+, data integrity, documentation standards, and inspection preparedness.
- Conduct root cause analyses (RCA) and develop risk-based quality improvement strategies.
- Advise on CTMS/eSource/eReg implementation to improve compliance, traceability, and audit trails.
- Support sponsors and sites with study start-up, monitoring readiness, and close-out activities.
- Provide strategic consulting to improve enrollment performance, documentation quality, and regulatory workflows.
- Collaborate with Principal Investigators, Sub-Investigators, CRAs, Sponsors, and CROs to resolve compliance issues efficiently.
Regulatory and Quality Assurance
Optimus U Corporation
Miami, FL
08.2022 - 06.2023
- Established and led the site’s Quality Assurance (QA) Program, creating structured processes for internal audits, compliance monitoring, and inspection readiness.
- Developed and implemented QA/QC SOPs for documentation standards, protocol compliance, and regulatory oversight.
- Conducted internal GCP audits of informed consent, source documentation, eligibility, safety reporting, IP accountability, and regulatory binders.
- Performed quality control (QC) reviews of source documents, eSource entries, regulatory files, and essential documents to ensure accuracy, completeness, and ALCOA+ compliance.
- Identified compliance gaps and led Corrective and Preventive Action (CAPA) development and implementation.
- Oversaw regulatory document management, including FDA 1572s, CVs, medical licenses, training logs, delegation logs, IRB submissions, and protocol amendments.
- Prepared the site for sponsor, CRO, and regulatory inspections through mock audits, staff coaching, and documentation reviews.
- Implemented quality tracking tools and compliance checklists to standardize workflows across studies.
- Monitored protocol deviations, adverse events, and regulatory timelines to ensure compliance with sponsor and IRB requirements.
- Collaborated with PIs, Sub-Investigators, Study Coordinators, and Sponsors to resolve compliance issues efficiently.
- Improved overall site readiness and inspection performance through proactive quality initiatives.
Clinical Research Project Manager
Premium Medical Research
Miami, FL
07.2019 - 08.2022
- Developed and maintained project timelines and budgets for multiple clinical trials.
- Oversaw regulatory submissions, ensuring compliance with FDA and IRB requirements.
- Mentored junior staff on best practices in clinical trial management and data integrity.
- Implemented process improvements that enhanced operational efficiency and data accuracy.
- Enhanced patient recruitment for clinical studies by developing targeted marketing materials and outreach strategies.
- Evaluated the performance of all team members involved in the projects regularly while providing constructive feedback for better results consistently.
- Coordinated with site investigators to ensure smooth execution of clinical trial protocols, addressing any challenges or concerns promptly.
- Conducted COVID-19 vaccine and antiviral clinical studies.
Clinical Research Coordinator
Ocean Blue Medical Research
Miami, FL
2016 - 2019
- Coordinated day-to-day clinical trial operations in accordance with study protocols, ICH-GCP, and FDA regulations.
- Conducted patient visits, including screening, consenting, eligibility review, and follow-up assessments.
- Performed phlebotomy and specimen processing per protocol requirements and laboratory manuals.
- Collected, documented, and maintained source documents ensuring ALCOA+ compliance.
- Created and maintained custom source templates aligned with protocol requirements.
- Entered study data into EDC systems accurately and within required timelines.
- Reviewed inclusion/exclusion criteria to ensure protocol eligibility compliance.
- Assisted with informed consent process, ensuring proper documentation and subject understanding.
- Maintained regulatory binders and essential documents in collaboration with the regulatory team.
- Prepared for and supported monitoring visits and audits.
- Ensured proper investigational product (IP) handling and accountability when applicable.
Education
Master of Science - Clinical Research
Arizona State University
Tempe, AZ2027
ACRP Certification - ACRP-CP
The Association of Clinical Research Professionals
01-2025
Bachelor of Arts - Interdisciplinary Arts
Florida International University
Miami, FL01-2024
Associate of Arts - Marketing
Florida International University
Miami, FL06.2018
Skills
- Regulatory Compliance & Interpretation
- Audit & Inspection Readiness Leadership
- CAPA Development
- Staff & PI Training
- Risk Assessment & Root Cause Analysis
- Data Integrity & Documentation Excellence
Certification
ACRP-CP Certified
CITI Certified
Viares Certified Professional
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Founder / Director of Quality Assurance
Modeli Research Consultants
06.2023 - Current
Regulatory and Quality Assurance
Optimus U Corporation
08.2022 - 06.2023
Clinical Research Project Manager
Premium Medical Research
07.2019 - 08.2022
Master of Science - Clinical Research
Arizona State University
Associate of Arts - Marketing
Florida International University
Clinical Research Coordinator
Ocean Blue Medical Research
2016 - 2019
ACRP Certification - ACRP-CP
The Association of Clinical Research Professionals
Bachelor of Arts - Interdisciplinary Arts
Florida International University