Regulatory Coordinator

Clinnova Research Solutions is a full-service Site Management Organization (SMO) supporting Phase II–IV clinical trials across Southern California. We're looking for a Regulatory Coordinator to join our Anaheim team and help keep our studies compliant, audit-ready, and running smoothly from start-up through close-out.

About the Role

As Regulatory Coordinator, you'll serve as the primary regulatory resource for our study teams, sponsors, and providers — preparing, submitting, and maintaining the documentation that keeps every trial in compliance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. You'll support studies from initiation through close-out, ensuring documentation is accurate, complete, and on time.

What You'll Do

• Serve as the primary regulatory point of contact for providers, sponsors, and the study team
• Submit regulatory documents (modifications, advertisements, continuing reviews, close-outs) to the IRB and other governing bodies
• Maintain site regulatory binders using CRIO, sponsor-specific eRegulatory platforms, and paper ISFs as needed
• Prepare and submit start-up documentation, including protocol amendments, informed consent documents, FDA Form 1572, financial disclosure forms, delegation of authority logs, licenses, and reports
• Maintain regulatory logs (temperature, subject enrollment, informed consent, monitoring visits, training)
• Lead study start-up and close-out from application through activation and final close-out
• Prepare for and serve as the primary regulatory contact during monitoring visits; independently resolve identified issues
• Write and update informed consent forms (ICFs) and HIPAA documents
• Prepare IRB submissions including SAEs, protocol deviations, and other required reports
• Process safety reports and maintain documentation of PI review
• Identify and report non-compliance or unanticipated problems; support root-cause analysis and CAPA development
• Maintain strict patient confidentiality in accordance with HIPAA and GCP guidelines

What We're Looking For

• Bachelor's degree in a health-related field (pharmacology, nursing, biology, or similar), or equivalent experience
• 1 year of clinical research regulatory experience
• Familiarity with central IRB processes and local, state, and federal regulatory requirements; working knowledge of FDA and GCP guidelines
• Strong organizational skills and the ability to prioritize and deliver accurate information under deadline
• Experience with eRegulatory systems (CRIO, Florence, etc.), IRB portals, and sponsor/vendor portals strongly preferred
• Comfortable working independently in a lean, fast-paced site environment

Why Clinnova

• Competitive pay, above-market for the region
• Healthcare (medical, dental, vision), paid time off, and 401(k)
• A close-knit team environment with real opportunity to grow into greater site responsibility over time

To apply: submit your resume and a brief note on your regulatory experience.

Pay: $67,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Education:

• Bachelor's (Required)

Experience:

• Site-Level Regulatory: 1 year (Required)

Ability to Commute:

• Anaheim, CA 92805 (Required)

Work Location: In person

Salary : $67,000 - $75,000