Temporary Clinical Research Regulatory Lead - IRB & Audits

University of California - Irvine; Fullerton (CA); On-site; USD 51,742 - 85,287; Full time

Benefits offered by this job

Medical insurance

Paid vacation

Holidays

Sick leave

Job summary

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator who will independently manage the regulatory lifecycle of clinical studies, prepare regulatory documents, and ensure audit readiness. The role requires collaboration with study teams and regulatory agencies to maintain compliance.

Minimum 3–5 years of regulatory experience and a bachelor's degree are required; preferred experience with OnCore and Complion.

Qualifications

• FDA regulations, GCP, IRB processes and trial regulatory requirements.
• Bachelor's degree or equivalent education with 3–5 years of regulatory experience.
• Preferred experience with OnCore and Complion electronic systems.
• Strong analytical, communication, and presentation skills for reports and improvements.

Responsibilities

• Manage activation, IRB submissions, continuing reviews, amendments, and study closeout.
• Prepare and maintain regulatory documents including informed consent and HIPAA authorizations.
• Collaborate with investigators, sponsors, and agencies to resolve compliance issues.
• Lead regulatory readiness for sponsor visits, audits, inspections, and quality initiatives.

Skills

FDA regulations

GCP

IRB processes

Regulatory requirements

Analytical skills

Presentation skills

Education

Bachelor's degree or equivalent

Tools

OnCore

Complion

Job description

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator who will independently manage the regulatory lifecycle of clinical studies, prepare regulatory documents, and ensure audit readiness. The role requires collaboration with study teams and regulatory agencies to maintain compliance.

Minimum 3–5 years of regulatory experience and a bachelor's degree are required; preferred experience with OnCore and Complion.