Senior Oncology Regulatory Specialist- CTO

OU Health Stephenson Cancer Center is Oklahomas only National Cancer Institute (NCI)-Designated Cancer Center and one of only 73 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 Senior Oncology Regulatory Specialist - CTO position under minimal supervision performs tasks with judgement and determines the proper course of action while following established standards. Responsible for coordinating regulatory and Institutional Review Board (IRB) activities of clinical research revisions to the Informed Consent Form and grant support. This position adheres to the University Compliance program Code of Ethics and Business Standards.

Learn more about the Stephenson Cancer Centers 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 a working knowledge of regulations submission requirements and processes for multiple regulatory systems.
• Help create and update regulatory workflows in collaboration with Clinical Trials Manager - Regulatory Affairs to adapt and adjust to changing regulations and processes.
• Training regulatory specialists on current or new processes and workflows. Provide guidance and instructions to regulatory specialists research personnel on regulatory affairs requirements and procedures.
• 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 for a team of regulatory specialist.
• Perform various duties as needed to successfully fulfill the functions of the position.

Required Education: Associates Degree

• 24 months of regulatory/compliance experience

Equivalence/Substitution:Will accept 24 months of equivalent experience in lieu of the Associates degree for a total of 48 months experience.

Skills:

• Advanced knowledge of compliance and regulatory concepts guidelines and principles.
• Advanced level of proficiency with Microsoft Office Suite and other software systems.
• Must be detail oriented and have excellent organization skills.
• Ability to communicate verbally and in writing.

Working Conditions:

• Physical:
  • Sit for prolonged periods.
  • Communicate effectively and listens.
  • Engage in repetitive motion.
  • Use of computer and telephone.
  • Stand stoop bend and reach.
• Environmental:
  • Standard office environment.

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