Clinical Regulatory Affairs Coordinator

Evolution Research Group; New York (NY); On-site; USD 42,000 - 65,000; Full time

Job summary

Evolution Research Group in New York, NY is seeking a Regulatory Affairs Assistant to support submission targets under the Regulatory Manager or Site Director. You will assist with collecting regulatory documents, maintaining logs, and preparing files in accordance with GCP/ICH, HIPAA, and SOPs.

This role emphasizes attention to detail, organizational skills, and proficiency with Microsoft Office. Experience in clinical research is preferred but not required; high school diploma or equivalent is

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.

Responsibilities

• General understanding of GCP/ICH guidelines.
• 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.

Skills

Attention to detail

Organizational skills

Microsoft Office proficiency

Medical terminology

Clinical research process

Education

High School Diploma

Two-year degree preferred

Tools

None

Job description

Evolution Research Group in New York, NY is seeking a Regulatory Affairs Assistant to support submission targets under the Regulatory Manager or Site Director. You will assist with collecting regulatory documents, maintaining logs, and preparing files in accordance with GCP/ICH, HIPAA, and SOPs.

This role emphasizes attention to detail, organizational skills, and proficiency with Microsoft Office. Experience in clinical research is preferred but not required; high school diploma or equivalent is