Clinical Trials Regulatory Affairs Specialist

UCI Health Regional Burn Center; Orange (CA); On-site; USD 52,000 - 85,000; Full time

Job summary

UC Irvine Center for Clinical Research (CCR) seeks a Regulatory Affairs Coordinator to manage the regulatory aspects of clinical trials. The role involves leading study-related meetings, maintaining the investigator site file, and ensuring compliant documentation across industry-sponsored, federally funded, and investigator-initiated studies.

You will ensure submissions to IRB, FDA, and sponsor monitors are timely, and maintain data in OnCore while adhering to GCP, SOPs, and university policies.

Qualifications

• Experience submitting IRB applications (Initial, Amendments, Continuing Reviews, and Reportable Events)
• Bachelor’s degree in a related field or equivalent experience
• HS graduation and related experience in regulatory affairs or clinical research
• Proven ability to research, evaluate information, and prepare reports and correspondence
• Ability to establish and maintain effective working relationships across a health system

Responsibilities

• Lead study-related meetings and manage the investigator site file.
• Ensure regulatory documentation is collected per study protocols.
• Oversee submissions to IRB, FDA, and sponsor monitors within required time frames.
• Maintain clinical trial information in the OnCore system and adhere to SOPs.
• Collaborate with investigators and study coordinators on regulatory aspects of non-cancer trials.

Skills

IRB submissions

Regulatory compliance

English communication

Clinical research

Regulatory affairs

Education

Bachelor’s degree or equivalent

HS graduation

Tools

OnCore

Microsoft Office

Job description

UC Irvine Center for Clinical Research (CCR) seeks a Regulatory Affairs Coordinator to manage the regulatory aspects of clinical trials. The role involves leading study-related meetings, maintaining the investigator site file, and ensuring compliant documentation across industry-sponsored, federally funded, and investigator-initiated studies.

You will ensure submissions to IRB, FDA, and sponsor monitors are timely, and maintain data in OnCore while adhering to GCP, SOPs, and university policies.