Clinical Trials Regulatory Specialist 1

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.

Core Duties:

• 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 new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.

• Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.

• Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.

• Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov.

• Collaborate on 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 and recommend related changes to leadership.

• May serve as 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, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.

Minimum Education and Experience

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

Knowledge, Skills and Abilities:

• Excellent communication skills and superb attention to detail.

• Experience with MS Office products and database applications required.

• Excellent inter-personal skills and customer service focus is required.

• 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.