Clinical Trials Regulatory Specialist 1

The Department of Anesthesiology, Perioperative, and Pain Medicine, at Stanford University’s School of Medicine, is a world-leading department that offers comprehensive training and perioperative patient care, pain management, and critical care medicine as well as cutting-edge research, encompassing a wide spectrum of programs in basic, translational, clinical, health services and medical education.

At Stanford University School of Medicine, the work we do touches the lives of those today and tomorrow. Through education, research, and health care, the School of Medicine improves health through leadership, diversity, collaborative discoveries, and innovation in health care. Whether working in departments with faculty, or in units that support the school, our staff are a part of teams that propel us on our journey toward the future of medicine and Precision Health.

Stanford is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends, and benefits that increase financial stability and promote healthy, fulfilling lives. An award-winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers.

The School of Medicine and the Department of Anesthesia are committed to diversity, equity, and inclusion for its faculty, staff, residents, postdocs, and fellows. We aim to recruit, support, retain, and promote diversity in our department.

Job Description:

The Regulatory Specialist will be responsible for preparing and submitting comprehensive regulatory packets for new clinical research studies, ensuring full compliance with Stanford HRPP and federal regulations. This role leads regulatory start-up activities by training research staff on IRB processes, addressing comment cycles, and offering ongoing regulatory guidance throughout the study lifecycle. The Specialist will coordinate and lead regular regulatory update meetings, maintain accurate records, and support PIs and study teams in responding to IRB inquiries and submitting necessary modifications. Must have strong knowledge of regulatory requirements related to drugs, medical devices, and artificial intelligence (AI) technologies in clinical research.

The position also involves department-wide oversight of regulatory submissions, with regular follow-ups to ensure timely completion of tasks such as continuing reviews and final reports. The Specialist will develop and maintain SOPs, quick reference guides, and best practice documents, delivering quarterly training sessions to improve submission efficiency and reduce delays. Staying current with regulatory changes, this individual will communicate key updates, advise leadership on internal policy adjustments, and serve as a liaison or escalation contact for safety reporting and audit-related regulatory matters.

Schedule: 10-20 hours per week 

Position length: 1 year with potential for extension

Work Arrangement: Hybrid

Work Location: 300 Pasteur

Core Duties:

• Prepare regulatory submission packets for PIs within the Department for new studies, including protocols, consent forms, and recruitment materials, ensuring full compliance with Stanford HRPP and federal regulations.
• Lead regulatory start-up activities for new clinical trials by training research staff on IRB processes, resolving study start up issues (responding to comment cycles) and offering continued regulatory support throughout the study lifecycle.
• Coordinate regulatory update meetings with key personnel regularly, ensure adherence to procedures, compile agendas and meeting minutes, and maintain session records in accordance with institutional standards.
• Assist PIs and their teams with responding to comment cycles or other questions from the IRB panel. Submit modifications as needed after reviewing current studies. If there is a recurring trend seen across multiple studies, create resolution guidance.
• Keep track of all regulatory submissions across the Department and regularly check in with CRCs to ensure tasks are being completed correctly and in a timely fashion i.e., continuing review, final report, etc.
• Create guidance documents for best practices in submitting to IRB both local and central. If there are recurring questions seen across the Departments submissions during the comment cycles pre-approval, create SOPs to mitigate future delays in approval. Author quick reference guides and deliver quarterly lunch & learn sessions.
• Stay updated on evolving research regulations and promptly communicate relevant changes to research teams, advising leadership on necessary adjustments to internal practices.
• Serve as either a primary liaison or a escalation contact for any issues related to safety and reporting. Attend meetings as needed to provide expertise on regulatory related items, including audits.
• Flexibility to work extended hours during audits; support audit and inspection readiness activities, including preparation and response to internal or external audits.

Education and Experience (Desired):

Three years of experience as a Clinical Trial Regulatory Specialist or at least 2 years of experience working within an Institutional Review Board (IRB) setting.

CT.gov, REDCap, OnCore experience preferred.

Education and Experience (Required):

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

Knowledge, Skills, and Abilities (Required):

• 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 (GCP).
• Knowledge of regulatory requirements related to drugs, medical devices, and artificial intelligence (AI) technologies in clinical research.
• Strong writing skills.

The expected pay range for this position is $51.00-57.00 per hour.

If interested, please send your resume here: https://app.smartsheet.com/b/form/019c0b6de64d71c5b3fe25d6990cfe2e