Regulatory Affairs Associate - Clinical Research

Summary

Regulatory Affairs Associate is available in the Department of Pediatrics, section of Neurology to support the successful execution of research by managing and coordinating all regulatory and administrative requirements. The Regulatory Affairs Associate will oversee the preparation, submission, and maintenance of essential regulatory documents, ensuring compliance with institutional, federal, and sponsor guidelines. The role also serves as a key resource to investigators and study teams, providing guidance on regulatory processes and helping streamline documentation workflows. Ideal candidates will be detail-oriented, highly organized, and capable of navigating complex regulatory environments while contributing to the overall efficiency and integrity of the lab’s research operations.

This position is eligible for a hybrid work schedule.

Job Duties

• Coordinate the preparation, submission, and maintenance of regulatory documents (e.g., IRB, IACUC, FDA submissions as applicable).
• Ensure timely and accurate completion of initial applications, amendments, continuing reviews, and reportable events.
• Maintain regulatory binders and electronic regulatory systems in accordance with institutional and sponsor requirements.
• Monitor study compliance and assist with internal and external audits, inspections, and monitoring visits.
• Provide guidance and support to investigators and research staff on regulatory requirements and processes.
• Track submission deadlines and ensure adherence to regulatory timelines.
• Assist in developing and implementing standard operating procedures (SOPs) and best practices for regulatory compliance.
• Serve as a liaison between research teams, institutional review boards, and other regulatory entities.
• Support onboarding and training of research staff on regulatory processes and documentation standards.
• Maintain knowledge of evolving regulatory requirements and communicate updates to relevant stakeholders.
• Perform other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Department Specific Criteria

• Must have experience with clinical research regulatory affairs.