Regulatory Affairs Coordinator (Open Rank: Intermediate – Senior)

University of Colorado Anschutz Medical Campus

Department: Neurology

Job Title: Regulatory Affairs Coordinator (Open Rank: Intermediate – Senior)

Position #:00841737 – Requisition #:40161

Job Summary:

The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for multi-site sponsored research studies relying on a central IRB. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; and training UCD Neurology Clinic Research personnel to promote good clinical practice (GCP) and compliance with all applicable regulations.  The Regulatory Affairs Coordinator will work closely with the Senior Clinical Research Regulatory Manager, subspecialty program managers, and clinical research coordinators.

Key Responsibilities:

• Facilitate completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc) 

• Create/organize regulatory binder and/or electronic files for new studies and maintain regulatory binder and/or electronic files throughout the course of the study, file/update all required documents and ongoing training/certifications appropriately

• Oversee training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study

• Maintain documentation of all relevant training

• Prepare for and manage regulatory portion of industry study monitor visits, addressing all regulatory action items

• Create informed consent documents for new studies and update informed consent documents as needed throughout the study

• Facilitate process for investigator receipt and evaluation of external IND safety reports

• Other duties as assigned

Work Location:

Hybrid – this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.

Why Join Us:

The University of Colorado Anschutz Medical Campus is the largest academic health center in the Rocky Mountain region at the forefront of transformative education, science, medicine, and healthcare. The campus includes the University of Colorado health professional schools, multiple centers, and institutes and two nationally ranked hospitals, UCHealth University of Colorado Hospital and Children’s Hospital Colorado, which trea