Clinical Trials Regulatory Lead

University of California, Irvine; Orange (CA); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical insurance

Sick and vacation time

Retirement savings plans

Job summary

The University of California, Irvine seeks a Regulatory Affairs Coordinator to oversee regulatory compliance for clinical trials. The role requires managing submissions to the IRB and FDA, ensuring adherence to study protocols. Candidates should have a Bachelor’s degree and 3-5 years in a related role, demonstrating strong communication and organizational skills. Familiarity with Microsoft Office and clinical trial regulations is preferred. This position offers benefits and requires occasional travel to research sites within California.

Qualifications

• 3-5 years of related work experience as a regulatory affairs coordinator or assistant.
• Experience submitting IRB applications.
• High level of integrity and ability to maintain confidentiality.

Responsibilities

• Manage regulatory aspects of clinical trials from initiation to completion.
• Ensure compliance with IRB and FDA regulations.
• Maintain clinical trial information in OnCore system.

Skills

Communication skills

Organizational skills

Critical thinking

Problem-solving

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office

Zoom

Job description

The University of California, Irvine seeks a Regulatory Affairs Coordinator to oversee regulatory compliance for clinical trials. The role requires managing submissions to the IRB and FDA, ensuring adherence to study protocols. Candidates should have a Bachelor’s degree and 3-5 years in a related role, demonstrating strong communication and organizational skills. Familiarity with Microsoft Office and clinical trial regulations is preferred. This position offers benefits and requires occasional travel to research sites within California.