Research Regulatory Coordinator

Intermountain Health Intermountain Medical Center

Full time

R179755

The purpose of this position is to provide regulatory research coordination to Intermountain research departments and to support research investigators, managers and directors as needed. The key responsibility of this position is to assure regulatory compliance with Institutional Review Board (IRB), sponsor, federal and state regulations pertaining to the protection of human subjects participating in research as according to Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines.

Join our research team as a Regulatory Research Coordinator , where you’ll play a key role in supporting investigators and research leaders while helping ensure the highest standards of regulatory compliance and protection for research participants. This position coordinates IRB and regulatory activities in accordance with sponsor, federal and state requirements, Good Clinical Practice (GCP), and ICH guidelines.

We’re looking for a collaborative, self-motivated professional who can work effectively both independently and as part of a team. Experience with IRB/regulatory submissions, physician investigators, or coordinating-center activities is highly valued.

This position supports a multi-year, grant-funded research project, with continued employment anticipated for the duration of the project and contingent upon ongoing grant funding and project needs.

• Hybrid role – Position requires on-site presence at times for training and meetings.
• Core business hours: Monday–Friday, 8:00 a.m. – 5:00 p.m.

• Research Coordination: Assist in the preparation, submission, and review of regulatory documents, including IRB applications, amendments, and single IRB submissions for multi-site studies. Ensure all study activities comply with regulatory requirements and institutional policies. Contacts and advises study staff and investigators in the preparation and completion of submissions.
• Compliance Monitoring: Monitor ongoing studies to ensure compliance with regulatory requirements, report adverse events, protocol deviations, unanticipated problems, and other events per institutional and sponsor reporting policies.
• Record Maintenance: Ensures application(s), study approval(s) and other relevant study documentation and information up to date and in compliance with federal, state and institutional requirements. Maintains up to date files (paper and electronic) of all regulatory documents and correspondence. Responsible for meeting with auditors and monitors reviewing regulatory files as requested and/or required on an ongoing basis and/or during the conduct of the clinical investigations.
• Communication: Communicate effectively with study sites, regulatory bodies, researchers, study teams, IRBs, sponsors, CROs, and other third parties. Acts as liaison to study teams to obtain necessary approvals and documentation.
• Training Support: Assist in the training of research staff on regulatory requirements, procedures, and best practices. Provide ongoing education on federal policies and regulations impacting human subject’s research.
• Meeting Coordination: Schedule and coordinate meetings related to study and regulatory compliance. Participate in site visits and audits conducted by sponsors, FDA, NIH, or other regulatory agencies.
• Document Management: Assist in drafting, reviewing, and maintaining informed consent documents to ensure they meet regulatory standards. Create forms and templates or complete forms as needed to comply with GCP and FDA standards.
• Regulatory Updates: Stay informed about changes in regulatory requirements and guidelines. Assist management in developing and executing…