OU Health Stephenson Cancer Center is Oklahoma’s only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 71 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options.

At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you! The Oncology Research Regulatory Specialist position, under direct supervision, performs tasks with discretion and asks questions to determine the proper course of action while following established standards. Assists with coordinating regulatory and Institution Review Board (IRB) activities of clinical research, revisions to the Informed Consent Form, and grant support. Adheres to University Compliance program, Code of Ethics, and Business Standards.

Learn more about the Stephenson Cancer Center’s Clinical Trials Office here.

Duties:

• Format, collect, and timely preparation of documents for regulatory submissions in accordance with FDA and trial sponsor specifications. Track collection progress through regulatory workflows.
• Maintain paper and/or electronic study trial file. Continually update the files and assist with the preparation for audits and sponsor visits.
• Assist with notifying IRB, study team, sponsors and regulatory agencies if applicable, of trial changes, enrollment status, and protocol deviations including the submission of continuing review data.
• Provide guidance and instructions to research personnel on regulatory affairs requirements and procedures with assistance from the supervisor. Assists with revisions to the Informed Consent Form (ICF) in compliance with sponsor and IRB requests.
• Assist with grant and contract support including submission of legal documents and associated routing forms to Office Research Administration and OU Medical Center.
• Maintain a working knowledge of regulations, submission requirements and processes for multiple regulatory systems.
• Adapt and adjust to changing regulations and processes while maintaining standardized regulatory operations and establishing clear documented workflows.
• Communicate important regulatory and study related information to the Research Team, Sponsors or regulatory authorities throughout the regulatory process.
• Independently manage and maintain a palette of studies with minimal supervision. Ensuring studies continue to meet regulatory, GCP and institutional guidelines and processes.
• Track milestones and ensure deadlines are met on multiple projects with minimal supervision.
• Perform various duties as needed to successfully fulfill the functions of the position.