Coordinator, Operations Support (IRB)

Job Description

Responsible for creating, submitting, and closing out studies that are submitted to Institutional Review Board (IRB) submissions for human subject research in cosmetics testing, while also driving AI-enabled process improvements across regulatory and operational workflows. This role blends regulatory expertise with innovation, ensuring studies are compliant and efficient.

JOB FUNCTIONS

• Assists in the development of study documents and study preparation for IRB studies
• Reviews and submits study protocols, informed consent forms, protocol deviations and adverse event reports, and supporting documentation to IRBs
• Tracks submission status, approvals, amendments, renewals, and closures
• Maintains accurate regulatory documentation and audit-ready files
• Engages with clients (when applicable) during study preparation phase to ensure all necessary documents (safety letter, informed consent, etc.) are finalized prior to IRB submission.
• Affords assistance in the development and updating of SOPs, WI, and training material related to study paperwork creation and IRB management.
• Ensures compliance with regulations.
• Identifies opportunities to apply AI (eg, automation tools) to streamline submission workflows
• Maintains performance metrics and continuously optimizes processes
• Provides excellent customer service to clients, and maintains positive interaction with peers and supervisors
• Adheres to internal standards, policies, and procedures.
• Performs other duties as assigned.

Qualifications

• Bachelor’s Degree, preferable in science or equivalent
• Minimum 1 year of experience in CRC position with SGS or equivalent clinical research organization, and/or prior project management experience.
• Excellent organizational and documentation skills.
• Proficiency with Microsoft Office applications, including Outlook, Word and Excel.
• Previous IRB experience and / or clinical research regulatory experience.
• Hands-on experience with AI tools for process automation, agent creation, and document creation.
• CCRC or CCRA Certification preferred
• Language Skills: Native-level English
• Mathematical and Reasoning Skills: Intermediate
• Work requires willingness to work a flexible schedule
• Longer hours, evenings and/or weekend work will be necessary occasionally as job duties demand

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.