Regulatory Affairs Assistant – Clinical Research

Barrington James; Miami (FL); On-site; USD 32,000 - 42,000; Full time

Benefits offered by this job

Medical/dental coverage

401(k) matching

Paid time off

Job summary

Barrington James in Miami is seeking a Regulatory Affairs Assistant to support documentation and compliance for Phase I–IV trials, reporting to Regulatory Manager and Site Director.

This entry point role focuses on study files, investigator documentation, and site regulatory records, providing hands-on experience in regulatory affairs within a clinical research setting. Onsite five days a week with a strong emphasis on accuracy.

Qualifications

• High School diploma or equivalent required; two-year degree preferred.
• Clinical research experience is desirable.
• Working knowledge of medical terminology and the clinical research process is a plus.
• Strong attention to detail and organizational skills; bilingual in Spanish/English.

Responsibilities

• Assist with collecting and preparing regulatory documents for submission to sponsors and IRBs.
• Help maintain current regulatory documents, including CVs, licenses, and training records.
• Support set-up of the electronic Investigator Site File (eISF) for active studies.
• Collect required signatures on regulatory documents.
• Maintain study logs (screening, enrollment, training).
• File study-related correspondence with sponsors and IRBs.
• Assist in resolving regulatory items identified during monitoring visits.
• Support document archiving following study closeout.
• Stay current on applicable SOPs, GCP, and other training requirements.

Skills

Attention to detail

Organizational skills

Microsoft Office

Bilingual Spanish/English

Education

High School diploma or equivalent

Two-year degree preferred

Tools

Electronic filing systems

eISF setup

Job description

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 IRBs
• Help maintain current regulatory documents, including CVs, licenses, and training records
• Support set-up of the electronic Investigator Site File (eISF) for active studies
• Collect required signatures on regulatory documents
• Maintain study logs (screening, enrollment, training)
• File study-related correspondence with sponsors and IRBs
• Assist in resolving regulatory items identified during monitoring visits
• Support document archiving following study closeout
• Stay current on applicable SOPs, GCP, and other training requirements

What We're Looking For

• High School diploma or equivalent required; two-year degree preferred
• Clinical research experience
• Working knowledge of medical terminology and the clinical research process is a plus
• Strong attention to detail and organizational skills
• Comfortable with Microsoft Office and electronic filing/document systems
• Bilingual 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.