Clinical Trials Regulatory Lead | Lab Manager

Stanford University; Palo Alto (CA); Sur place; USD 120 000 - 160 000; Plein temps

Résumé du poste

Stanford University is seeking a Clinical Trial Regulatory Lab Manager for the Stanford Innovative Neurotherapeutics Center (SINC) to oversee regulatory compliance of clinical research within SINC and act as the university's liaison with external regulatory agencies, both domestic and international.

The role requires experience with human subjects in clinical trials, IRB processes, NIH/NIMH regulatory work, and strong communication skills, with responsibility for submissions, safety reporting,

Qualifications

• Experience with human subjects in clinical trials/clinical research for 5–6 years including oversight of recruitment, enrollment, study close out, sponsor correspondence, and PI support.
• Experience with University IRB processes and NIH/NIMH regulatory procedures.
• Strong written and verbal communication skills.
• Understanding of the full clinical trial process including NIH interactions, trial site management, and IRB coordination.
• Experience with NIH and/or industry/external sponsors.

Responsabilités

• Prepare regulatory submissions (IRB, IND/IDE) and annual reports; maintain regulatory documents and agency correspondence.
• Serve as an expert liaison for regulatory compliance between investigators and agencies; provide guidance to investigators and staff.
• Develop education and training materials for the research community; prepare communications and orientations.
• Oversee regulatory documentation, safety reporting procedures, and audit safety reports.
• Evaluate regulatory changes and implement within the unit; ensure compliance with laws and university policies.
• Serve as primary liaison on safety issues with IRB and other internal committees.
• May manage projects related to regulatory activities and develop regulatory strategy for teams.
• May hire and supervise regulatory staff; provide daily supervision and performance evaluations.
• Contribute to SOP development to align with regulatory requirements.

Connaissances

Clinical trials experience

IRB knowledge

NIH/NIMH regulatory processes

Communication skills

Regulatory affairs knowledge

Sponsor coordination

Problem-solving

Formation

Bachelor's degree + 5 years experience

Description du poste

Stanford University is seeking a Clinical Trial Regulatory Lab Manager for the Stanford Innovative Neurotherapeutics Center (SINC) to oversee regulatory compliance of clinical research within SINC and act as the university's liaison with external regulatory agencies, both domestic and international.

The role requires experience with human subjects in clinical trials, IRB processes, NIH/NIMH regulatory work, and strong communication skills, with responsibility for submissions, safety reporting,