IRB & Regulatory Research Coordinator

Intermountain Healthcare Inc.

United States

Hybrid

USD 65,000 - 95,000

Full time

3 days ago

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Job summary

Intermountain Healthcare Inc. is seeking a Regulatory Research Coordinator to support IRB submissions, regulatory filings, and GCP/ICH compliance across research projects. The role collaborates with investigators, managers, and directors to ensure participant protection and adherence to federal, state, and institutional policies.

The position is hybrid with on-site training and meetings as needed; core hours are Monday through Friday, 8:00 a.m. to 5:00 p.m.

Qualifications

Experience coordinating IRB submissions and regulatory documents.
Knowledge of GCP, ICH guidelines, and FDA/IRB processes.
Strong communication and organizational skills.
Experience in a regulatory, compliance, healthcare or research role.

Responsibilities

Assist in preparation, submission, and review of regulatory documents (IRB applications, amendments, single IRB submissions).
Monitor studies for regulatory compliance and report adverse events or deviations.
Maintain regulatory files and respond to audits and monitors.
Communicate with study sites, IRBs, sponsors, CROs, and investigators.
Assist in training research staff on regulatory requirements and policies.
Coordinate meetings and site visits related to study and compliance.
Draft, review, and maintain informed consent documents and regulatory templates.
Stay updated on regulatory changes and assist in policy development.