Clinical Trials Regulatory Specialist

Job Description

Job Description

The National Institute of Clinical Research, a leading research organization serving the pharmaceutical and biotechnology industries, is seeking a Clinical Trials Regulatory Specialist with 2 or more years of experience, to join our team.

We are looking for a skilled and motivated individual responsible for preparing, reviewing, and maintaining regulatory documents and submissions to ensure full compliance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. This role plays a critical part in supporting clinical trial start-up, maintenance, and close-out activities, ensuring all required documentation is accurate, complete, and submitted in a timely manner.

Responsibilities include :

• 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.

Qualifications :

Preferred Skills :

Candidates must be local to Orange County, CA area

Location

Benefits

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