Clinical Trials Regulatory Specialist

Utah; Salt Lake City (UT); On-site; USD 33,000 - 75,000; Full time

Job summary

Huntsman Cancer Institute at the University of Utah is seeking a Regulatory Coordinator to develop and coordinate regulatory submissions to ensure compliance with governing requirements. The role supports regulatory processes, communications with IRB, and trackings of approvals and expirations.

Position is full-time at the Campus location, with duties including document preparation, policy guidance, and regulatory reporting to maintain study integrity and compliance with FDA/ICH/GCP guidelines.

Qualifications

• Bachelor's degree in a research or related area plus two years of clinical trials/research experience.
• Equivalency statement allowing one year of higher education to substitute for one year of related work experience.

Responsibilities

• Supports all aspects of regulatory compliance.
• Prepares regulatory documents, including consent forms for submission to research review committees.
• Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions.
• Tracks study approvals and expirations to ensure uninterrupted project approval.
• Submits study renewal applications and study progress reports to the IRB.
• Maintains regulatory database.
• Generates ad hoc reports as requested.

Skills

Regulatory knowledge

Medical terminology

Technical writing

Communication skills

Microsoft Office

Education

Bachelor's degree

Clinical trials/research experience

Job description

Huntsman Cancer Institute at the University of Utah is seeking a Regulatory Coordinator to develop and coordinate regulatory submissions to ensure compliance with governing requirements. The role supports regulatory processes, communications with IRB, and trackings of approvals and expirations.

Position is full-time at the Campus location, with duties including document preparation, policy guidance, and regulatory reporting to maintain study integrity and compliance with FDA/ICH/GCP guidelines.