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Oncology Research Regulatory Specialist

1 month ago

Norman, United States THE UNIVERSITY OF OKLAHOMA Full time

OU Health Stephenson Cancer Center is Oklahoma's only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 72 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 a?airs 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 O?ce 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.

Education: Associate's degree AND:

  • 12 months of regulatory and/or compliance experience

Preferred Experience: 12 months of clinical research experience

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

degree for a total of 36 months experience.

Skills
  • Advanced knowledge of compliance and regulatory concepts, guidelines, and principles.
  • Advanced level of pro?ciency with Microsoft O?ce Suite and other software systems.
  • Must be detail oriented and have excellent organizational skills.
  • Ability to communicate verbally and in writing.
Working Conditions
  • Physical: Sit for prolonged periods. Communicate effectively and actively listen. Engage in repetitive motion. Use of computer and telephone. Stand, stoop, bend, and reach.
  • Environmental: Standard office environment.

Why You Belong at the University of Oklahoma: The University of Oklahoma fosters an inclusive culture of respect and civility, belonging, and access, which are essential to our collective pursuit of excellence and our determination to change lives. The unique talents, perspectives, and experiences of our community enrich the learning, and working environment at OU, inspiring us to harness our innovation, creativity, and collaboration for the advancement of people everywhere.

Equal Employment Opportunity Statement: The University of Oklahoma, in compliance with all applicable federal and state laws and regulations, does not discriminate based on 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.