Stanford University School of Medicine · 8 hours ago
Regulatory Specialist (Hybrid Opportunity)
Stanford, CA
Full-time
Hybrid
Mid, Senior Level
$123K/yr - $144K/yr
5+ years expStanford University School of Medicine is seeking a Clinical Trials Regulatory Specialist II to support their active clinical trials faculty. The role involves preparing regulatory submissions, serving as a liaison between investigators and regulatory agencies, and overseeing regulatory documentation to ensure compliance with various regulations.
EducationHigher EducationMedical
Responsibilities
Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required
Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development
Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions
Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled
Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance
Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees
May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams
May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance
May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation
Qualification
Required
Bachelor's degree and five years of related experience or a combination of education and relevant experience
Excellent communication and organizational 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 research management and oversight, including project management in a dynamic research setting
Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice
Experience in developing and implementing training/education
Demonstrated ability to manage multiple projects and staff under varying time constraints
Strong writing skills
Preferred
Experience with Protocol/IND writing
Experience with BMT-CT disease focus
Benefits
Career development programs
Tuition reimbursement
Superb retirement plans
Generous time-off
Family care resources
Health care benefits
Free commuter programs
Ridesharing incentives
Discounts
Company
Stanford University School of Medicine
Stanford University School of Medicine is the medical school of Stanford University. It is a sub-organization of Stanford University.
5001-10000 employees
H1B Sponsorship
Stanford University School of Medicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (551)
2024 (499)
2023 (472)
2022 (390)
2021 (336)
2020 (260)
Funding
Current Stage
Late StageTotal Funding
$10MKey Investors
American Medical Association
2023-06-21Grant
2017-07-19Grant· $10M
Leadership Team
Darius M. Moshfeghi
Chief of Retina Division: Vitreoretinal Surgery and Medical Diseases
Quinton R. Markett
Research Professional, Utz Lab, Department of Medicine, Division of Immunology & Rheumatology
Recent News
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