Regulatory Affairs Associate - Clinical Research

1w1 week ago

Baylor College of Medicine

Houston, US · Full-time · $65,000 – $85,000

About this role

The Regulatory Affairs Associate supports successful research execution in the Department of Pediatrics, section of Neurology by managing and coordinating regulatory and administrative requirements. Oversees preparation, submission, and maintenance of essential regulatory documents. Ensures compliance with institutional, federal, and sponsor guidelines.

Serves as a key resource to investigators and study teams, providing guidance on regulatory processes. Helps streamline documentation workflows while navigating complex regulatory environments. Contributes to the overall efficiency and integrity of the lab’s research operations.

Coordinates with research teams, institutional review boards, and regulatory entities as a liaison. Monitors study compliance and assists with audits, inspections, and monitoring visits. Supports onboarding and training of research staff on documentation standards.

Assists in developing standard operating procedures and best practices for regulatory compliance. Tracks submission deadlines and maintains knowledge of evolving requirements. Position eligible for a hybrid work schedule.

Requirements

Bachelor's degree
Two years of relevant experience
Experience with clinical research regulatory affairs
Detail-oriented
Highly organized
Capable of navigating complex regulatory environments

Responsibilities

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
Serve as a liaison between research teams, institutional review boards, and other regulatory entities
Maintain knowledge of evolving regulatory requirements and communicate updates to relevant stakeholders