Clinical Trials Regulatory Assistant

Ergclinical; Miami (FL); On-site; USD 23,419 - 30,307; Full time

Job summary

Evolution Research Group (ERG) is seeking a Regulatory Affairs Assistant for the CPMI-Clinical Pharmacology unit in Miami, FL. This full-time role supports regulatory submissions under the Regulatory Manager, aligning with GCP, ICH, and HIPAA standards.

Responsibilities cover administrative tasks, document collection, site file setup, keeping logs, and maintaining training records. Experience in clinical research is preferred but not required; a high school diploma or equivalent is required.

Qualifications

• Working knowledge of medical terminology and the clinical research process.
• Attention to detail.
• Organizational Skills.
• Strong computer skills, including knowledge of all components of Microsoft Office are required.
• Clinical Research experience preferred but not required.
• High School Diploma or its equivalent; Two-year degree preferred.

Responsibilities

• Assist with collecting and preparing regulatory documents for submission to sponsor and IRB.
• Assist with maintaining current regulatory‑related documents to include CVs, licenses, and required training documents.
• Assist with set‑up of electronic Investigator Site File for all awarded studies.
• Collect signatures on regulatory documents as required.
• Assist with maintaining current study logs such as Screening and Enrollment Logs, Training Logs.
• Assist with filing study‑related correspondence (sponsor, IRB, etc.) in the Investigator Site File.
• Assist with resolution to regulatory items identified during monitoring visits.
• Maintain current training with applicable SOPs/WIs, GCP, etc.
• Assist with archiving of study documents following study closure.
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization.

Skills

Attention to detail

Organizational skills

Strong computer skills

Education

High School Diploma

Two-year degree preferred

Tools

Microsoft Office

Job description

Evolution Research Group (ERG) is seeking a Regulatory Affairs Assistant for the CPMI-Clinical Pharmacology unit in Miami, FL. This full-time role supports regulatory submissions under the Regulatory Manager, aligning with GCP, ICH, and HIPAA standards.

Responsibilities cover administrative tasks, document collection, site file setup, keeping logs, and maintaining training records. Experience in clinical research is preferred but not required; a high school diploma or equivalent is required.