IRB Submissions & Operations Coordinator — AI-Driven

SGS; Richardson (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

SGS is seeking an IRB study regulatory specialist to manage human subject research submissions in cosmetics testing and drive AI-enabled improvements across regulatory workflows.

You will prepare and submit IRB studies, maintain audit-ready documentation, and collaborate with clients to ensure complete, compliant submissions. A background in CRC and regulatory practice with AI tool experience is valued. Flexible scheduling may be required.

Qualifications

• Bachelor’s Degree, preferable in science or equivalent.
• Minimum 1 year of CRC experience with SGS or equivalent clinical research org or project management experience.
• Excellent organizational and documentation skills.
• Proficiency with Microsoft Office applications, including Outlook, Word and Excel.
• Previous IRB experience or clinical research regulatory experience.
• Hands-on AI tools for process automation and document creation.
• CCRC or CCRA Certification preferred.
• Native-level English language skills.
• Intermediate mathematical and reasoning skills.
• Willingness to work a flexible schedule.
• Occasional longer hours, evenings, or weekends as needed.

Responsibilities

• Assists in developing study documents and preparation for IRB studies.
• Reviews and submits study protocols and consent forms to IRBs.
• Tracks submission status, approvals, amendments, renewals, and closures.
• Maintains regulatory documentation and audit-ready files.
• Interacts with clients during study preparation to finalize documents.
• Assists with SOP, WI, and training material development for IRB management.
• Ensures compliance with regulations.
• Identifies AI-based opportunities to streamline submissions.
• Monitors performance metrics to optimize processes.
• Delivers excellent customer service and maintains professional interactions.
• Adheres to internal standards and procedures.
• Performs additional duties as assigned.

Skills

Regulatory expertise

Project management

Documentation

Customer service

AI tools familiarity

English communication

Education

Bachelor's degree in science or equivalent

CCRC or CCRA certification preferred

Tools

Microsoft Office (Outlook, Word, Excel)

Job description

SGS is seeking an IRB study regulatory specialist to manage human subject research submissions in cosmetics testing and drive AI-enabled improvements across regulatory workflows.

You will prepare and submit IRB studies, maintain audit-ready documentation, and collaborate with clients to ensure complete, compliant submissions. A background in CRC and regulatory practice with AI tool experience is valued. Flexible scheduling may be required.