Clinical Regulatory Specialist

Overview

We are seeking a motivated and organized individual who is interested in starting a career in clinical research. This entry-level role will assist with preparing, reviewing, and maintaining regulatory documents and submissions in accordance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. The position supports clinical trial start-up, ongoing study activities, and close-out processes, ensuring documentation is accurate, complete, and submitted on time.

Comprehensive training and ongoing support will be provided, making this a great opportunity for someone eager to learn and grow in the clinical research field.

• Prepare and submit regulatory documents (e.g., 1572s, CVs, financial disclosures, protocol submissions, IRB submissions, etc.) for clinical studies.
• Track and maintain essential regulatory documents in accordance with sponsor and regulatory requirements.
• Communicate with Institutional Review Boards (IRBs), sponsors, and internal departments to ensure regulatory compliance and timely approvals.
• Maintain Trial Master File (TMF)/Investigator Site File (ISF) and ensure inspection-readiness.
• Monitor study timelines and proactively manage submission deadlines and expirations.
• Support study start-up and close-out activities by coordinating required documentation.
• Assist with audits and inspections as needed.
• Stay current with relevant regulations, guidelines, and industry best practices.
• Travel to other site locations will be required.

• Bachelor’s degree
• Excellent organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office Suite / Google Suite

• Experience working with IRBs and regulatory agencies.
• Familiarity with CTMS or electronic document management systems.
• Clinical Research Coordinator (CRC) or Regulatory Affairs Certification (RAC) is a plus.
• Minimum of 1-2 years experience.

• Must be local to Los Angeles & Orange County, CA areas only.
• Los Angeles, CA Area
• Full-time
• This is a hybrid position for the right candidate

Medical Insurance, Dental & Vision Insurance, 401k, PTO

Flexible work from home options available.