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.

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.

Travel to other site locations will be required.

Qualifications:

Bachelor’s degree

Excellent organizational skills and attention to detail.

Excellent written and verbal communication skills.

Proficiency with Microsoft Office Suite / Google Suite

Preferred Skills:

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.

Location:

Los Angeles, CA Area

Full-time

This is a hybrid position for the right candidate

Benefits

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

Flexible work from home options available.