Sr. Oncology Research Regulatory Specialist

University of Oklahoma

Oklahoma, OK

Job posting number: #7135652 (Ref:ta230713)

Posted: March 22, 2023

Application Deadline: Open Until Filled

Job Description

Job Description

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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 Senior Oncology Regulatory Specialist 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 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 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.


 

Job Requirements

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Education: Associate’s Degree



Experience: 24 months of regulatory/compliance experience



Equivalence/Substitution: Will accept 24 months of equivalent experience in lieu of the Associate's 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.



Diversity Statement: The University of Oklahoma is committed to achieving a diverse, equitable, and inclusive university community by recognizing each person's unique contributions, background, and perspectives. The University of Oklahoma strives to cultivate a sense of belonging and emotional support for all, recognizing that fostering an inclusive environment for all is vital in the pursuit of academic and inclusive excellence in all aspects of our institutional mission.



Equal Employment Opportunity Statement: The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate on the basis of race, color, national origin, sex, sexual orientation, genetic information, gender identity, gender expression, age, religion, disability, political beliefs, or status as a veteran in any of its policies, practices, or procedures. This includes, but is not limited to, admissions, employment, financial aid, housing, services in educational programs or activities, and health care services that the University operates or provides.


 




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Job posting number:#7135652 (Ref:ta230713)
Application Deadline:Open Until Filled
Employer Location:University of Oklahoma
Norman,Oklahoma
United States
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