Protocol Registration and Reporting: Responsible for all aspects of trial registration and accrual reporting to ensure compliance with National Cancer Institute (NCI), Food and Drug Administration (FDA), and other applicable regulations and policies.
Investigator/Staff Credentialing: Responsible for maintaining, collecting, and tracking documentation of investigator and research staff credentials and updating internal and sponsor required databases and files.
Regulatory Support: Assists regulatory specialists as needed, including collection of study specific essential documents (Form 1572, financial disclosures, etc.), delegation documentation, preparing for monitoring and auditing activities; provides support to regulatory team for data entry into Clinical Trials Management System (CTMS) and other internal databases.
Training and mentorship to student workers, education designees, and administrative staff in the conduct of regulatory support activities.
Performs assigned tasks with high level of oversight.
Maintains department or clinic compliance with a high level of guidance.
Conducts internal and external audits and activities to support regulatory agency inspections.
Prepares, completes and submits all compliance documentation on a routine basis. Coordinates compliance committee meetings.
Performs other related work as needed.
Project management experience
Prior work experience in clinical research regulatory compliance, research operations, coordinator, or data management
Demonstrated ability to communicate effectively in written and oral formats
Familiarity with MS Office applications
Cover letter (preferred)
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Internal Number: JR09182
About University of Chicago (UC)
One of the world's premier academic and research institutions, the University of Chicago has driven new ways of thinking since our 1890 founding. Today, UChicago is an intellectual destination that draws inspired scholars to our Hyde Park and international campuses, keeping UChicago at the nexus of ideas that challenge and change the world.