Coordinator, Operations Support (IRB)
On-siteRichardson, Texas, United States
Job Summary
Create, submit, and close out IRB studies for human subject research in cosmetics testing while driving AI-enabled process improvements across regulatory workflows. Review and submit protocols, informed consent forms, and adverse event reports to IRBs, then track submission statuses, approvals, amendments, and renewals. Maintain accurate, audit-ready regulatory documentation and engage with clients during study preparation to finalize necessary documents. Assist in developing SOPs, WI, and training materials, ensuring full compliance with regulations. Identify opportunities to apply automation tools for streamlined submissions and monitor performance metrics to optimize processes. Requires flexible scheduling with occasional evening or weekend work.
Required Qualifications
- Bachelor's Degree, preferable in science
- 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
- Native-level English
- Intermediate Mathematical and Reasoning Skills
- Willingness to work a flexible schedule
- Longer hours, evenings and/or weekend work will be necessary occasionally as job duties demand
Desired Qualifications
- CCRC or CCRA Certification preferred
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