Regulatory Specialist - Clinical Research

Benefits

Qualifications

• •0–3+ years of experience in clinical research, regulatory work, or a related healthcare field
• •Strong organizational skills and attention to detail
• •Ability to work independently while collaborating with cross-functional teams
• •Strong written and verbal communication skills with a professional and ethical approach to work
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Responsibilities

• •Schedule: Monday–Thursday 7:30 AM–5 PM, with occasional Friday mornings
• •The Regional Regulatory Specialist supports clinical research studies by managing regulatory documentation and coordinating submissions to oversight bodies
• •This role partners closely with site leadership, investigators, and sponsors to ensure studies meet regulatory requirements and internal standards
• •The specialist maintains essential study documentation, prepares regulatory submissions, and supports inspections, monitoring visits, and audits
• •This position is ideal for someone who is organized, detail-oriented, and interested in growing within the clinical research field
• •Prepare and maintain regulatory binders and documentation for clinical research studies
• •Coordinate regulatory submissions and updates to IRBs, sponsors, and other oversight agencies
• •Track and maintain essential documents such as CVs, licenses, and training records
• •Ensure regulatory files remain accurate, organized, and compliant with study protocols and federal regulations
• •Support monitoring visits, audits, and regulatory reviews
• •Maintain both electronic and paper regulatory records while protecting confidential patient and study information
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