Regulatory Affairs Coordinator (Open Rank: Senior-Principal)

**Regulatory Affairs Coordinator (Open Rank: Senior-Principal)**

**Description**

**University of Colorado Anschutz Medical Campus**

**Department: Ophthalmology**

**Job Title: Regulatory Affairs Coordinator (Open Rank: Senior-Principal)**

**Position #00846414 - Requisition #39535**

**Job Summary:**

Key Responsibilities:

+ Prepare, submit, and manage regulatory documents for IRB submissions (COMIRB, Advarra, etc), including initial submissions, continuing reviews, amendments, reportable events, and study closures.
+ Coordinate regulatory documentation for multi-site and industry-sponsored clinical trials.
+ Maintain complete and audit-ready regulatory binders in accordance with institutional, sponsor, and regulatory requirements.
+ Ensure compliance with ICH-GCP, FDA regulations, institutional policies, and sponsor requirements.
+ Track and maintain investigator qualifications, including CVs, medical lice...

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