Temporary Clinical Research Regulatory Coordinator

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

Overview

University of California, Irvine is hiring a Temporary Clinical Research Regulatory Coordinator. The role involves independently managing the regulatory lifecycle of clinical research studies, preparing and maintaining regulatory documentation, collaborating with study teams and regulatory agencies, and ensuring compliance with regulatory requirements through audit readiness and quality improvement.

Responsibilities

• Manage study activation, IRB submissions, continuing reviews, amendments, reportable events, study closeout, and document archiving for clinical trials
• Prepare and maintain regulatory documents such as informed consent forms, HIPAA authorizations, electronic regulatory binders (Complion), and OnCore records
• Collaborate with principal investigators, sponsors, and regulatory agencies to resolve compliance issues and manage protocol deviations and serious adverse events
• Lead regulatory readiness for sponsor monitoring visits, audits, inspections, and quality improvement initiatives

Qualifications and Experience

• Required knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and regulatory requirements for Phase I–III clinical trials
• Minimum 3–5 years of clinical research regulatory experience and bachelor's degree or equivalent combination of education and experience
• Preferred experience with electronic clinical research systems like OnCore and Complion
• Strong analytical, communication, and presentation skills to support report generation and process improvements

Compensation and Employment Type

• Pay rate ranges from $37.56 to $61.91 per hour
• Temporary full-time position with benefits including medical insurance, paid vacation, holidays, and sick leave