Regulatory Lead, Clinical Trials & Lab Operations

School of Medicine; Palo Alto (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

Stanford University’s Stanford Innovative Neurotherapeutics Center (SINC) seeks a Clinical Trial Regulatory Lab Manager to oversee administration and regulatory compliance of clinical research at SINC, representing Stanford with external agencies, both domestic and international.

You will coordinate IRB/IND/IDE submissions, liaise with investigators, and guide staff to ensure adherence to FDA, NIH, and IRB requirements for safe, compliant trial progress.

Qualifications

• Bachelor’s degree and five years of related experience.
• Experience with NIH/NIMH regulatory processes.
• Experience with FDA regulations, IRB review and approval process.
• Strong written and verbal communication and organizational skills.
• Ability to manage multiple regulatory projects and staff.

Responsibilities

• Prepare regulatory submissions (IRB and IND/IDE) and annual reports. Maintain correspondence with regulatory agencies.
• Serve as liaison between investigators and regulatory agencies; provide guidance to investigators and staff.
• Develop, deliver and manage training materials for the research community and orientation sessions.
• Oversee regulatory documentation and safety reporting procedures; audit safety reports for compliance.
• Evaluate impact of new regulations and implement changes within the unit; ensure compliance with laws and university policies.
• May manage projects related to regulatory activities and clinical operations; develop regulatory strategy for project teams.
• May hire and supervise regulatory staff and provide performance feedback.
• Contribute to SOP development for conduct of clinical research to ensure compliance.

Skills

Strong communication

Organizational skills

Regulatory liaison

Project management

Education

Bachelor’s degree

Tools

MS Office

Database applications

Job description

Stanford University’s Stanford Innovative Neurotherapeutics Center (SINC) seeks a Clinical Trial Regulatory Lab Manager to oversee administration and regulatory compliance of clinical research at SINC, representing Stanford with external agencies, both domestic and international.

You will coordinate IRB/IND/IDE submissions, liaise with investigators, and guide staff to ensure adherence to FDA, NIH, and IRB requirements for safe, compliant trial progress.