Job Description:

Come join the staff at OU HSC and become a part of Oklahoma's premier research university which leads the state in education and career opportunities!

Duties:

• Under minimal supervision, responsible for coordinating regulatory and Institution Review Board (IRB) activities of clinical research being conducted at the University.


• Adheres to University Compliance Program, Code of Ethics, and Business Standards.


• Coordinates collection of required documentation from research sites in accordance with Food and Drug Administration (FDA) and trial sponsor specifications.


• Tracks collection progress through the regulatory process.


• Maintains a paper and/or electronic study trial file.


• Continually updates and prepares files for audits.


• Responsible for notifying IRB of trial changes, enrollment status, and protocol deviations including submission of continuing review data.


• Provides guidance and instructions to research personnel on regulatory affairs requirements and procedures.


• Assist with revisions to Informed Consent Form (ICF) in compliance with sponsor and IRB requests.


• Provides grant support including submission of legal documents and associated routing forms to Office Research Administration (ORA) and OU Medical Center.


• Performs various duties as needed to successfully fulfill the functions of the position.

Required Education: Bachelors Degree, AND:

• 12 months regulatory experience in a clinical research environment.

Equivalency/Substitution: Will accept 48 months equivalent regulatory experience in lieu of the Bachelors Degree for a total of 60 months regulatory 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 perform tasks with judgment and determine proper course of action while following established standards.


• Ability to communicate verbally and in writing.

Advertised Physical Requirements:

• 
  Physical: Sitting for prolonged periods. Manual dexterity. Speaking and listening.


• 
  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.

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