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. OU HSC is one of only four comprehensive academic health centers in the nation with seven professional colleges. We are currently building world-class institutes for the treatment of diabetes and cancer. We are looking for a Research Regulatory Specialist to join our team.
Under general supervision, the Research Regulatory Specialist performs tasks with discretion and ability to make judgments and determine proper course of action while following established standards. Responsible for coordinating regulatory and Institution Review Board (IRB) activities of clinical research being conducted at the University. Adheres to OU HSC Compliance program, Code of Ethics, and Business Standards.
Duties\:
- Data Collection\: Coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications\: Tracks collection progress through the regulatory process.
- Files\: Maintains a paper and/or electronic study trial file. Continually updates and prepares files for audits.
- Notification of Changes\: Responsible for notifying IRB of trial changes, enrollment status, and protocol deviations including submission of continuing review data.
- Compliance\: 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.
- Grants and Contracts\: Provides grant support including submission of legal documents and associated routing forms to Office Research Administration and OU Medical Center.
- As Needed\: Performs various duties as needed to successfully fulfill the functions of the position.
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. OU HSC is one of only four comprehensive academic health centers in the nation with seven professional colleges. We are currently building world-class institutes for the treatment of diabetes and cancer. We are looking for a Research Regulatory Specialist to join our team.
Under general supervision, the Research Regulatory Specialist performs tasks with discretion and ability to make judgments and determine proper course of action while following established standards. Responsible for coordinating regulatory and Institution Review Board (IRB) activities of clinical research being conducted at the University. Adheres to OU HSC Compliance program, Code of Ethics, and Business Standards.
Duties\:
- Data Collection\: Coordinates collection of required documentation from research sites in accordance with FDA and trial sponsor specifications\: Tracks collection progress through the regulatory process.
- Files\: Maintains a paper and/or electronic study trial file. Continually updates and prepares files for audits.
- Notification of Changes\: Responsible for notifying IRB of trial changes, enrollment status, and protocol deviations including submission of continuing review data.
- Compliance\: 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.
- Grants and Contracts\: Provides grant support including submission of legal documents and associated routing forms to Office Research Administration and OU Medical Center.
- As Needed\: Performs various duties as needed to successfully fulfill the functions of the position.
Required Education\: High School Diploma or GED
Skills\:
- High level of organization skills
- Knowledge of compliance and regulatory concepts, guidelines, and principles.
- Proficiency with Microsoft Office Suite and other software systems.
- Ability to read and understand instructions.
- Ability to communicate verbally and in writing.
Working Conditions\:
- Physical\:
- Sitting for prolonged periods.
- Manual dexterity.
- Reaching, speaking, and listening.
- Environment\:
- Standard Office Environment.
Why You Belong at the University of Oklahoma\: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here!
Equal Employment Opportunity Statement\: The University, 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, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practice.
Required Education\: High School Diploma or GED
Skills\:
- High level of organization skills
- Knowledge of compliance and regulatory concepts, guidelines, and principles.
- Proficiency with Microsoft Office Suite and other software systems.
- Ability to read and understand instructions.
- Ability to communicate verbally and in writing.
Working Conditions\:
- Physical\:
- Sitting for prolonged periods.
- Manual dexterity.
- Reaching, speaking, and listening.
- Environment\:
- Standard Office Environment.
Why You Belong at the University of Oklahoma\: The University of Oklahoma values our community's unique talents, perspectives, and experiences. At OU, we aspire to harness our innovation, creativity, and collaboration for the advancement of people everywhere. You Belong Here!
Equal Employment Opportunity Statement\: The University, 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, marital status, genetic information, gender identity/expression (consistent with applicable law), age (40 or older), religion, disability, political beliefs, or status as a veteran in any of its policies, practice.
Required Attachments
Documents required for this position are listed under the "Required Attachments" section of this job listing. You will be required to upload and attach these documents in the application process.
Important: ALL required documents must be attached to your job application or your documents will not be visible to the hiring department!
Legal & Compliance (1)