Regulatory Specialist - Clinical Research
Behavioral Health Market Context
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Benefits
Competitive pay of $24–$29/hour, depending on experienceComprehensive benefits including medical, dental, vision, 401(k) with 4% match, PTO, and paid holidaysWork in a collaborative, mission-driven environment focused on research that improves lives
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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