Clinical Trials Regulatory Specialist 1

Stanfordlivetickets; Palo Alto (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

The Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research. The role emphasizes HRPP/IRB coordination, regulatory submissions, and ongoing compliance across drugs, devices, and AI-enabled studies.

You will train investigators and staff, develop SOPs, and monitor submissions while guiding teams through IRB inquiries and continuing

Qualifications

• Experience supporting regulatory submissions for clinical trials.
• Ability to guide investigators through IRB processes and HRPP requirements.
• Strong understanding of regulatory documentation and quality systems.

Responsibilities

• Support study start-up and regulatory submissions from concept to activation.
• Provide regulatory guidance and training to investigators and staff.
• Develop and maintain SOPs and reference guides for regulatory practices.
• Monitor regulatory submissions and ensure timely continuing reviews and reports.

Skills

Regulatory compliance

IRB submissions

IRB processes

Training delivery

SOP development

Job description

The Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research.

What the Role Entails

Supporting Study Start-Up and Regulatory Submissions.This position supports new clinical research studies from concept to activation by preparing and submitting regulatory packets. The role supports compliance with Stanford's Human Research Protection Program (HRPP) and applicable federal regulations while guiding research teams through Institutional Review Board (IRB) processes, from initial submission and responses to comments through final approval.

Providing Regulatory Guidance and Training.This position provides practical training and ongoing regulatory guidance to investigators and research staff throughout the study lifecycle. The specialist coordinates regular regulatory update meetings to keep teams informed of relevant requirements and process changes. As a department resource for principal investigators and study teams, the specialist helps navigate IRB inquiries, modifications, and submissions and applies relevant regulatory requirements to research involving drugs, medical devices, and artificial intelligence technologies.

Supporting Department-Wide Regulatory Compliance.The specialist monitors regulatory submissions across the department and follows up to support timely completion of continuing reviews and final reports. The role develops and maintains standard operating procedures (SOPs), quick-reference guides, and best-practice documents to support consistent regulatory practices. The specialist delivers quarterly training sessions to improve submission quality and efficiency, reduce avoidable delays, and keep department personnel informed of regulatory changes.

Supporting Compliance and Process Improvement.The role advises departmental leadership on operational and policy adjustments in response to evolving regulations and serves as a liaison and escalation contact for safety reporting and audit-related matters. The specialist helps develop systems and processes that support consistent and efficient regulatory compliance.

About the Department

Join a world-leading department at the forefront of medical innovation. Our 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.

Why Stanford Medicine?

Impact That Matters. At Stanford University School of Medicine, we're pioneering the future of Precision Health through leadership, diversity, and collaborative discovery. Every role contributes to our mission of improving health worldwide.

Invest in the Future. Stanford offers career development programs tailored to professional growth, competitive compensation that reflects market trends and expertise, and comprehensive benefits supporting financial stability and work-life balance. Our award-winning culture is rooted in excellence, innovation, collaboration, and lifelong learning.

Join Something Extraordinary. Be part of a team propelling medicine forward. At Stanford, the work is challenging, contributions matter, and careers thrive.