Regulatory Affairs Assistant – Clinical Research

About The Opportunity Join a well-established, high-volume clinical research site in Miami as a Regulatory Affairs Assistant. This is a great entry point into clinical research regulatory work — supporting the documentation and compliance side of Phase I-IV clinical trials rather than pharmaceutical regulatory strategy or FDA submissions. You'll work closely with the Regulatory Manager and Site Director to keep study files, investigator documentation, and site regulatory records accurate, current, and inspection-ready. What You'll Do Assist with collecting and preparing regulatory documents for submission to sponsors and IRBsHelp maintain current regulatory documents, including CVs, licenses, and training recordsSupport set-up of the electronic Investigator Site File (eISF) for active studiesCollect required signatures on regulatory documentsMaintain study logs (screening, enrollment, training)File study-related correspondence with sponsors and IRBsAssist in resolving regulatory items identified during monitoring visitsSupport document archiving following study closeoutStay current on applicable SOPs, GCP, and other training requirements What We're Looking For High School diploma or equivalent required; two-year degree preferredClinical research experience Working knowledge of medical terminology and the clinical research process is a plusStrong attention to detail and organizational skillsComfortable with Microsoft Office and electronic filing/document systemsBilingual in Spanish/English Must be able to work onsite five days a week in Miami, FL Why You'll Like It This role is a strong fit for someone looking to build a career in clinical research regulatory affairs — whether you're coming from a Clinical Research Coordinator, Clinical Research Assistant, or healthcare administrative background, or simply have the organizational skills and interest to grow into the space. Comprehensive benefits including medical/dental coverage, 401(k) matching, and paid time off.