Sr. Oncology Regulatory Specialist - CTO

University of Oklahoma•Oklahoma City, OK

About The Position

OU Health Stephenson Cancer Center is Oklahoma’s only National Cancer Institute (NCI)-Designated Cancer Center and one of 74 NCI-Designated Cancer Centers in the United States. The Senior Oncology Regulatory Specialist joins the Clinical Trials Office and serves as a regulatory expert, working independently and exercising expertise and sound judgment. The role supports oncology clinical research by coordinating IRB submissions, managing informed consent revisions, supporting grant activities, and ensuring studies meet ethical, compliance, and scientific standards. The position also supports Cancer Center strategic initiatives and NCI reporting requirements and works with clinical research teams to facilitate regulatory compliance and efficient workflows.

Requirements

  • Bachelor’s degree, or experience or a combination of education and related experience in lieu of a degree; a one-to-one ratio is used to determine the years of experience required in place of a degree.

Responsibilities

  • Track and manage regulatory submissions for oncology clinical trials.
  • Manage informed consent updates to ensure clarity and compliance.
  • Support Cancer Center strategic initiatives and NCI reporting requirements with regulatory documentation.
  • Ensure adherence to University Compliance, Code of Ethics, and Business Standards.
  • Guide study teams through regulatory requirements.
  • Maintain audit-ready records and essential documents.
  • Collaborate across departments to streamline regulatory workflows.
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