Jessica Pimentel
Miami
Summary
Detail-oriented Regulatory Affairs Professional with 9+ years of experience in clinical research, regulatory compliance, and trial coordination. Proven expertise in ICH-GCP, FDA, and IRB guidelines, with a strong record of managing regulatory submissions, supporting audits, and serving as a key liaison between investigators, sponsors, and IRBs. Adept at developing regulatory documentation, maintaining compliance systems, and ensuring operational excellence in clinical trials.
Overview
11
11
years of professional experience
Work History
Regulatory Specialist
Mount Sinai Comprehensive Cancer Center
Miami Beach
07.2016 - 07.2025
- Coordinated site-selection, initiation, and closure of clinical trials for internal and external IRBs.
- Prepared informed consent forms (ICFs) and regulatory submissions to IRBs and sponsors.
- Maintained eBinders, submitted annual trial reviews, and tracked consent versions.
- Reported adverse events per IRB/sponsor policies and ensured audit readiness for NCI, industry, and FDA inspections.
- Served as a regulatory resource for research staff and physicians.
Clinical Research Assistant
Boca Biolistics
Pompano
06.2015 - 06.2016
- Assembled and maintained regulatory binders and compliance documentation.
- Conducted SIVs, interim monitoring, and close-out visits.
- Drafted and edited CRFs, protocols, and ICFs; liaised with IRBs for protocol variances.
- Performed site audits and quality control of regulatory submissions.
Lab Operations Technician
Boca Biolistics
Pompano
11.2014 - 06.2015
- Processed and inventoried biological materials in compliance with GMP and IATA regulations.
- Maintained laboratory equipment, PPE, and cleanliness logs per SOPs.
Education
Bachelor of Arts - Biological Sciences, Psychology
Florida Atlantic University
Boca Raton, FLAssociate of Arts -
Broward College
Davie, FLSkills
- Regulatory Submissions & Compliance
- ICH-GCP
- FDA
- IRB Guidelines
- Clinical Trial Start-Up & Close-Out
- Audit Preparation & Support
- Informed Consent Form Development
- Regulatory Binder Management
- Document Tracking & Version Control
- Bilingual Communication (English/Spanish)
Languages
- English
- Spanish
Timeline
Regulatory Specialist
Mount Sinai Comprehensive Cancer Center
07.2016 - 07.2025
Clinical Research Assistant
Boca Biolistics
06.2015 - 06.2016
Lab Operations Technician
Boca Biolistics
11.2014 - 06.2015
Bachelor of Arts - Biological Sciences, Psychology
Florida Atlantic University
Associate of Arts -
Broward College