Remote Clinical Trials Regulatory Lead

Stanford University; United States; Remote; USD 90,000 - 120,000; Full time

Job summary

Stanford University, Division of Body MRI within the Department of Radiology, seeks a Clinical Trials Regulator Specialist to coordinate planning for regulatory approval and commercialization of MRI contrast agent technologies.

This remote opportunity requires strong organizational skills, experience with regulatory affairs, and collaboration with investigators, sponsor representatives, and ARPA-H to advance translational research toward regulatory submission and potential commercialization.

Qualifications

• Bachelor's degree required; three years of related experience.
• Experience in clinical trials operations or IRB processes preferred.
• Knowledge of regulatory affairs and FDA regulations.

Responsibilities

• Independently develop regulatory submissions and materials per university and external policies.
• Manage new study initiation, educate staff and sponsors, resolve issues and provide regulatory guidance.
• Coordinate meetings, prepare sponsorship documentation and billing, and maintain session records.
• Stay current on federal and local regulations and recommend related changes to leadership.
• May co-author responses to investigators and ensure timely communication with stakeholders.

Skills

Excellent communication skills

Attention to detail

MS Office proficiency

Regulatory knowledge

FDA regulations knowledge

Good Clinical Practice

Interpersonal skills

Customer service focus

Education

Bachelor's degree

Tools

MS Office

Database applications

Job description

Stanford University, Division of Body MRI within the Department of Radiology, seeks a Clinical Trials Regulator Specialist to coordinate planning for regulatory approval and commercialization of MRI contrast agent technologies.

This remote opportunity requires strong organizational skills, experience with regulatory affairs, and collaboration with investigators, sponsor representatives, and ARPA-H to advance translational research toward regulatory submission and potential commercialization.