Clinical Trials Regulatory Lead (IRB/IND)

Stanford University School of Medicine; Palo Alto (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

The Stanford Innovative Neurotherapeutics Center (SINC) within Stanford University seeks a Clinical Trial Regulatory Lab Manager to oversee regulatory compliance for clinical research at SINC, and to serve as the university's liaison with domestic and international regulatory agencies.

The role requires extensive experience with human subjects in clinical trials, IRB processes, NIH/NIMH regulations, and managing regulatory submissions, safety reporting, and protocol support across trials.

Qualifications

• Experience with human subjects in clinical trials/clinical research for 5–6+ years, including recruitment, enrollment, and sponsor correspondence.
• Experience with University IRB and NIH/NIMH regulatory processes.
• Strong communication skills, both written and verbal.
• Understanding of the Clinical Trial process from start to finish including NIH interactions and IRB coordination.
• Experience with NIH and/or industry sponsors.
• Ability to manage sites, communicate with investigators, participants, and study coordinators.
• Demonstrated problem-solving, tact, and diplomacy in regulatory settings.

Responsibilities

• Prepare regulatory submissions (IRB and IND/IDE) and annual reports; maintain regulatory documents.
• Serve as liaison between investigators and regulatory agencies; provide guidance and protocol input.
• Develop and deliver training materials for the research community.
• Oversee regulatory documentation and safety reporting procedures.
• Evaluate impact of new regulations and ensure compliance with applicable laws and policies.
• Serve as primary liaison on safety issues with IRB, OSR, RMG or other bodies.
• May manage regulatory projects and develop regulatory strategy for teams.
• May hire, orient, and supervise regulatory staff; provide performance feedback.
• Contribute to SOP development for clinical research operations.

Skills

Clinical trials

IRB processes

FDA regulations

NIH interactions

Regulatory submissions

Communication skills

Project management

Stakeholder liaison

Diplomacy

Education

Bachelor's degree

Job description

The Stanford Innovative Neurotherapeutics Center (SINC) within Stanford University seeks a Clinical Trial Regulatory Lab Manager to oversee regulatory compliance for clinical research at SINC, and to serve as the university's liaison with domestic and international regulatory agencies.

The role requires extensive experience with human subjects in clinical trials, IRB processes, NIH/NIMH regulations, and managing regulatory submissions, safety reporting, and protocol support across trials.