Research Regulatory Coordinator

Job Description:

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.

Work Schedule Hybrid Role:
This position requires on-site presence at least once per week, or more frequently based on department and business needs.

Core business hours:
Monday–Friday, 8:00 a.m. – 5:00 p.m.Essential Functions 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 institutional policies and procedures to ensure compliance with federal, state, and local laws and regulations related to research.

Skills Accountability Critical  Thinking Work collaboratively

Verbal and Written Communication Detail-oriented

Prioritization

Time-management

Proficient in Microsoft Writing Regulatory Minimum  Qualifications Experience in a role requiring effective organizational skills; effective follow-through, and commitment to excellence, effective professional communication skills:
Ability to communicate with others in a clear, understandable, and professional manner as well as strong interpersonal skills:
Ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment.

Experience working collaboratively in a team environment.

Experience using word processing, spreadsheet, database, internet and e-mail and scheduling applications.

Demonstrated years’ experience in a regulatory, compliance, healthcare or research role.

Preferred Qualifications Bachelor's Degree in a clinical or life science field, business, or healthcare operations. A degree must be obtained through an accredited institution. Education is verified.

Regulatory and compliance experience.

Experienc…