Regulatory Specialist

None • NJ, US • published 2026-09-19 11:37:38.768530

Description

**Position Summary** The Regulatory Specialist is responsible for managing and maintaining the regulatory documentation and compliance requirements for clinical research studies, clinical trials, and other human subjects research projects. This position supports study start\-up, IRB submissions, regulatory binders, essential document management, protocol amendments, continuing reviews, reportable events, staff training documentation, and audit readiness. The Regulatory Specialist ensures that research studies are conducted in compliance with applicable regulatory standards, sponsor requirements, IRB expectations, organizational policies, and ethical standards for human subjects protection. **Essential Duties and Responsibilities** **Regulatory Study Start\-Up** * Review study protocols, consent forms, investigator brochures, manuals of procedures, and sponsor materials. * Prepare and coordinate regulatory documents required for study activation. * Assist with site feasibility, start\-up checklists, regulatory document collection, and study readiness. * Develop and maintain regulatory binders or electronic regulatory files for assigned studies. * Ensure required approvals are obtain...

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