Senior Clinical Trials Regulatory Lead

Abundance Network; United States; On-site; USD 100,000 - 140,000; Full time

Job summary

Stanford University’s Stanford Innovative Neurotherapeutics Center (SINC) at the Lucile Packard Children’s Hospital seeks a Clinical Trial Regulatory Lab Manager to oversee regulatory compliance of clinical research and to represent the university with domestic and international regulators.

This 1-year fixed-term role requires 5–6 years of experience in human subjects research, IRB processes, NIH interactions, strong communication, and the ability to manage multiple sites and projects while

Qualifications

• Bachelor’s degree and five years of related experience.
• Experience with human subjects in clinical trials/clinical research for 5–6 years including recruitment and PI support.
• Experience with University IRB.
• Experience with NIH/NIMH regulatory processes.
• Strong written and verbal communication skills.

Responsibilities

• Prepare regulatory submissions (IRB and IND/IDE) and annual reports.
• Serve as expert liaison between investigators and regulatory agencies; provide regulatory guidance to PIs and staff.
• Develop, deliver and manage training materials and communications for the research community.
• Oversee regulatory documentation, safety reporting procedures and audit safety reports.
• Evaluate impact of new regulations and ensure compliance with global and local rules.
• Serve as primary liaison on safety issues with IRB, OSR, and internal committees.
• Manage projects related to regulatory activities and develop regulatory strategy for teams.
• May hire, orient and train regulatory staff and supervise tasks.
• Contribute to SOP development for conduct of clinical research.

Skills

Clinical trials

Regulatory affairs

Communication skills

Project management

IRB experience

NIH interactions

Education

Bachelor's degree

Tools

MS Office

Database applications

Job description

Stanford University’s Stanford Innovative Neurotherapeutics Center (SINC) at the Lucile Packard Children’s Hospital seeks a Clinical Trial Regulatory Lab Manager to oversee regulatory compliance of clinical research and to represent the university with domestic and international regulators.

This 1-year fixed-term role requires 5–6 years of experience in human subjects research, IRB processes, NIH interactions, strong communication, and the ability to manage multiple sites and projects while