Trials Regulatory Specialist: Start-Up & Compliance

Abundance Network; United States; On-site; USD 80,000 - 100,000; Full time

Job summary

Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research. You will guide investigators through HRPP and IRB processes, prepare regulatory packets, and maintain compliance across projects.

You will train study teams, develop SOPs, and serve as a regulatory resource across the department, ensuring timely submissions and adherence to FDA,

Qualifications

• Bachelor’s degree and three years of related experience.
• Experience with clinical research regulatory requirements and IRB processes.
• Knowledge of FDA regulations and Good Clinical Practice (GCP).

Responsibilities

• Develop and compile regulatory submission documents in compliance with policies.
• Guide study teams through regulatory start-up and submissions processes.
• Coordinate regulatory updates and trainings for investigators and staff.
• Maintain regulatory documents and SOPs; support timely continuing reviews and final reports.
• Liaise with IRB, OSR, and internal committees on safety and reporting procedures.
• Assist with ClinicalTrials.gov registrations and reporting as needed.
• Stay current on regulations and communicate changes to leadership.

Skills

Communication skills

Interpersonal skills

Writing skills

MS Office

Customer service

Regulatory knowledge

Education

Bachelor's degree

Tools

MS Office

Database applications

Job description

Stanford Medicine's Department of Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research. You will guide investigators through HRPP and IRB processes, prepare regulatory packets, and maintain compliance across projects.

You will train study teams, develop SOPs, and serve as a regulatory resource across the department, ensuring timely submissions and adherence to FDA,