Clinical Trials Regulatory Specialist 1

About the Role

The Clinical Trials Regulatory Specialist 1 provides centralized regulatory support for a diverse portfolio of clinical research within the Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Medicine.

• Supports new clinical research studies from concept to activation by preparing and submitting regulatory packets.
• Ensures compliance with Stanford's Human Research Protection Program (HRPP) and applicable federal regulations.
• Guides research teams through Institutional Review Board (IRB) processes, including initial submission, responses to comments, and final approval.
• Provides practical training and ongoing regulatory guidance to investigators and research staff throughout the study lifecycle.
• Coordinates regular regulatory update meetings to keep teams informed of relevant requirements and process changes.
• Serves as a department resource for principal investigators and study teams, helping navigate IRB inquiries, modifications, and submissions for research involving drugs, medical devices, and artificial intelligence technologies.
• Monitors regulatory submissions across the department and follows up to support timely completion of continuing reviews and final reports.
• Develops and maintains standard operating procedures (SOPs), quick-reference guides, and best-practice documents to support consistent regulatory practices.
• Delivers quarterly training sessions to improve submission quality and efficiency, reduce avoidable delays, and keep department personnel informed of regulatory changes.
• Advises departmental leadership on operational and policy adjustments in response to evolving regulations.
• Serves as a liaison and escalation contact for safety reporting and audit-related matters.
• Helps develop systems and processes that support consistent and efficient regulatory compliance.

Responsibilities

• Independently develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
• Manage and oversee the new study initiation process, including educating study staff and sponsors, resolving issues, and providing regulatory guidance and support.
• Facilitate and participate in committee meetings, ensuring procedures are followed.
• Compile, organize, and store all session documentation and communicate results as appropriate.
• Revise submissions for identified problems and issues, resolve procedural issues to ensure timely response, and advise investigators on remedies and revisions.
• Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents.
• Assist with registering and reporting of clinical trials (e.g., ClinicalTrials.gov).
• Collaborate on the development of standard operating procedures, trainings, and documentation; may participate in delivering trainings.
• Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff; recommend related changes to leadership.
• May serve as the primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG, or other internal organizations or committees.
• May co-author committee responses to investigators, ensure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.

Requirements

• Bachelor’s degree and three years of related experience or a combination of education and relevant experience.

Skills

• Excellent communication skills and superb attention to detail.
• Experience with MS Office products and database applications.
• Excellent interpersonal skills and customer service focus.
• Experience in clinical trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
• Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Strong writing skills.

About the Department

Join a world-leading department at the forefront of medical innovation. The Department of Anesthesiology, Perioperative and Pain Medicine's comprehensive portfolio spans cutting-edge clinical trials and translational research, advanced patient care in anesthesiology, pain management, and critical care, plus health services research and medical education excellence.

Benefits

• Career development programs tailored to professional growth.
• Competitive compensation that reflects market trends and expertise.
• Comprehensive benefits supporting financial stability and work-life balance.

Stanford's award-winning culture is rooted in excellence, innovation, collaboration, and lifelong learning.