Clinical Regulatory Specialist: Submissions & Compliance

Elite Clinical Network; Scottsdale (AZ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading clinical research organization located in Scottsdale, Arizona, is seeking a Regulatory Coordinator to ensure clinical trial compliance by preparing, submitting, and maintaining all regulatory documents required for study initiation and conduct. The successful candidate will support investigators and internal teams while ensuring adherence to FDA regulations and IRB processes. Previous regulatory experience is preferred, along with strong organizational and communication skills.

Qualifications

• Prior experience performing regulatory duties is preferred but not mandatory.
• Strong understanding of FDA regulations, ICH-GCP guidelines, and IRB processes.
• Excellent organizational and communication skills with strong attention to detail.
• Proficient in Microsoft Office Suite and electronic regulatory systems.

Responsibilities

• Prepare, submit, and maintain all essential regulatory documents for clinical trials.
• Coordinate initial and continuing review submissions and protocol amendments.
• Maintain regulatory binders and trial master files for compliance.
• Track submission deadlines, approval expirations, and critical regulatory timelines.
• Communicate with sponsors, CROs, and study monitors regarding documentation.

Skills

Organizational skills

Communication skills

Attention to detail

Understanding of FDA regulations

Proficiency in Microsoft Office Suite

Tools

eReg

CTMS

Job description

A leading clinical research organization located in Scottsdale, Arizona, is seeking a Regulatory Coordinator to ensure clinical trial compliance by preparing, submitting, and maintaining all regulatory documents required for study initiation and conduct. The successful candidate will support investigators and internal teams while ensuring adherence to FDA regulations and IRB processes. Previous regulatory experience is preferred, along with strong organizational and communication skills.