Job Summary Table of Regulatory Specialist

Regulatory Specialist Job Description Summary

Stanford University is seeking a dedicated Clinical Trials Regulatory Specialist 2 to oversee compliance, administration, and regulatory aspects of clinical research within the Divisions of Stroke and Neurocritical Care. This critical role will represent the university with both domestic and international regulatory agencies and provide comprehensive regulatory support to numerous Principal Investigators. The position includes responsibility for regulatory oversight of at least one Stanford-led multi-site research study, covering Industry Sponsored, federally funded, and PI-initiated trials.

Key Regulatory Specialist Responsibilities

• Regulatory Documentation Management 📋 — Prepare regulatory submissions including IRB applications, IND/IDE submissions, and annual reports. Maintain all necessary documentation and correspondence with regulatory agencies, ensuring timely submission of updates and reports.

• Expert Liaison Services 🔄 — Serve as a specialized compliance and scientific liaison between investigators and regulatory agencies. Provide comprehensive guidance and regulatory support to principal investigators and research staff, with potential consultation on protocol development.

• Education and Training Development 📚 — Create, implement, and manage educational tools and training materials for the research community. Conduct presentations, one-on-one training, and orientation sessions to ensure regulatory compliance across teams.

• Safety Reporting and Documentation 🛡️ — Oversee and maintain regulatory documentation and safety reporting procedures. Audit safety reports to ensure appropriate handling and compliance with all regulations.

• Regulatory Analysis and Implementation 📊 — Evaluate new regulations and determine implementation strategies within the unit. Apply comprehensive knowledge of international, federal, state, and local regulations as well as university policies to ensure optimal compliance.

• Safety Liaison ⚕️ — Act as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG, and other internal organizations or committees.

• Project Management 📝 — Manage various projects related to regulatory activities and clinical operations. Develop strategic regulatory approaches for project teams.

• Staff Supervision 👥 — May hire, train, and directly supervise regulatory staff. Assign work tasks, provide daily supervision, and conduct performance evaluations.

• Standard Operating Procedures 📑 — Contribute to the establishment and development of SOPs for clinical research conduct, ensuring compliance with all regulations while meeting clinical research operational objectives.

Benefits and Perks

• Comprehensive rewards package through Stanford’s Cardinal at Work program
• Competitive salary range ($120,551 to $134,914 per annum)
• Career growth opportunities within Stanford’s prestigious medical research environment
• Collaborative work environment with leading researchers
• Professional development opportunities

Company Overview

Stanford University is one of the world’s leading teaching and research institutions, dedicated to finding solutions to big challenges and preparing students for leadership in a complex world. Known for entrepreneurial innovation and academic strength, Stanford’s faculty and students extend the University’s reach beyond campus through online learning initiatives and philanthropy, making Stanford an international institution in the truest sense.

Stanford University Culture

Stanford’s culture promotes excellence, innovation, and intellectual exploration. The university values collaboration across disciplines to address complex problems in medicine and other fields. Employees enjoy a vibrant campus environment, rich with cultural and educational opportunities, and a community dedicated to improving human health through groundbreaking research.

Career Growth Opportunities in Regulatory Affairs

This position offers significant potential for career advancement within Stanford’s medical research ecosystem. Regulatory specialists have opportunities to develop specialized expertise in various therapeutic areas, advance to senior regulatory roles, or transition to broader clinical research management positions. The exposure to cutting-edge clinical trials provides valuable experience that is highly regarded throughout the healthcare and pharmaceutical industries.

Diversity, Equity, Inclusion, and Belonging at Stanford

Stanford University is deeply committed to fostering a diverse, equitable, and inclusive workplace. The university actively promotes an environment where individuals from all backgrounds can thrive and contribute their unique perspectives to advance medical research and improve patient outcomes.

Equal Opportunity Statement

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Remote Work Policy

This position is designated as on-site, requiring regular presence at Stanford’s facilities. May require occasional local and overnight travel. Stanford provides appropriate accommodations for employees with disabilities to perform essential job functions.

Application Process

1. Review the complete job description and requirements
2. Prepare your resume and supporting documents
3. Apply through Stanford’s career portal
4. Participate in the interview process if selected

How to Apply

Interested candidates should apply directly through Stanford University’s career portal at the link provided above. For questions about the application process, please contact Stanford University Human Resources by submitting a contact form through their website.

FAQs or Additional Information

Physical Requirements: This position requires the ability to frequently sit, grasp lightly, use fine manipulation, and perform desk-based computer tasks. The candidate must be able to lift, carry, push, and pull objects weighing up to ten pounds.

Working Conditions: The position may require occasional local and overnight travel. The successful candidate will be expected to comply with all applicable University policies and procedures, including personnel policies and other policies found in the University’s Administrative Guide.

Accommodation: Consistent with its obligations under the law, Stanford University will provide reasonable accommodations to applicants and employees with disabilities. Applicants requiring accommodation should contact Stanford University Human Resources.

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