Clinical Research Regulatory Coordinator: IRB, Audits, OnCore

UC Irvine; California (MO); On-site; USD 104,698,000 - 112,963,000; Full time

Benefits offered by this job

Medical Insurance

Retirement Savings Plans

Discounts and Perks

Job summary

UC Irvine seeks a regulatory professional to independently manage the regulatory lifecycle of clinical research studies, including study activation, IRB submissions, continuing reviews, amendments, and study closeout.

You will prepare and oversee regulatory documents, collaborate with investigators, sponsors, and regulatory agencies, and support sponsor monitoring visits, audits, and inspections to ensure compliance with FDA and GCP.

Qualifications

• Bachelor's degree in a related field or equivalent experience.
• 3–5 years of regulatory experience in clinical research.
• Knowledge of FDA regulations, GCP, IRB processes, and trials.
• Healthcare/clinical research environment experience; strong organization.
• Ability to read and write English clearly.

Responsibilities

• Manage regulatory lifecycle: activation, IRB submissions, continuing reviews, amendments, SAEs, closeout, archiving.
• Prepare and oversee regulatory docs: informed consent, HIPAA authorizations, investigator site files, electronic binders (Complion), OnCore.
• Collaborate with PIs, study teams, sponsors, and regulators to resolve issues and ensure compliance.
• Lead regulatory readiness for sponsor visits, audits, inspections, and generate regulatory reports.

Skills

Regulatory lifecycle management

FDA regulations

IRB processes

OnCore

Complion

Project coordination

English communication

Education

Bachelor's degree in related field

Tools

Complion

OnCore

Job description

UC Irvine seeks a regulatory professional to independently manage the regulatory lifecycle of clinical research studies, including study activation, IRB submissions, continuing reviews, amendments, and study closeout.

You will prepare and oversee regulatory documents, collaborate with investigators, sponsors, and regulatory agencies, and support sponsor monitoring visits, audits, and inspections to ensure compliance with FDA and GCP.