Clinical Trials Regulatory Specialist II

Stanford University; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Stanford University’s Clinical Research Hub (CRH) seeks a mission-driven Clinical Trials Regulatory Specialist 2 to ensure regulatory compliance and effective collaboration across clinical operations and sponsors.

The role involves interface with study teams, IRBs, FDA, and other authorities, requiring strong communication, integrity, and project-management skills. The position supports flexible onsite, hybrid, or remote work arrangements to advance global clinical research initiatives.

Qualifications

• Experience with regulatory submissions.
• Knowledge of Good Clinical Practices (GCP) and SOPs.
• Ability to collaborate with sponsors, investigators, and study teams.

Responsibilities

• Ensure compliance with GCP and SOPs.
• Collaborate with clinical operations, QA, education, and business development managers.

Skills

Regulatory compliance

Communication

Project management

Interpersonal skills

Job description

Stanford University’s Clinical Research Hub (CRH) seeks a mission-driven Clinical Trials Regulatory Specialist 2 to ensure regulatory compliance and effective collaboration across clinical operations and sponsors.

The role involves interface with study teams, IRBs, FDA, and other authorities, requiring strong communication, integrity, and project-management skills. The position supports flexible onsite, hybrid, or remote work arrangements to advance global clinical research initiatives.