National Institute of Clinical Research · 8 hours ago
Clinical Regulatory Specialist
Los Angeles, CA
Full-time
Hybrid
Entry Level
1+ years expNational Institute of Clinical Research is seeking a motivated and organized individual for an entry-level Clinical Regulatory Specialist position. The role involves preparing, reviewing, and maintaining regulatory documents and submissions in compliance with FDA regulations and ICH-GCP guidelines, while supporting clinical trial activities and ensuring timely documentation completion.
Clinical TrialsMedicalProfessional Services
Responsibilities
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
Qualification
Required
Bachelor's degree
Excellent organizational skills and attention to detail
Excellent written and verbal communication skills
Proficiency with Microsoft Office Suite / Google Suite
Preferred
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
Benefits
Medical Insurance
Dental & Vision Insurance
401k
PTO
Flexible work from home options available.
Company
National Institute of Clinical Research
The National Institute of Clinical Research (NICR) is a physician owned and managed, independent, multi-site Clinical Trial Management Organization.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Sali Aswad
Owner
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