*Senior Clinical Trials Compliance Specialist

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 Senior Clinical Trials Compliance Specialist performs auditing of site-specific and affiliate clinical trials and investigator-initiated studies, monitors protocol compliance and may supervise Clinical Trials Office Staff.

Duties:

• Performs auditing of site-specific and affiliate clinical trials in compliance with federal, sponsor, and internal guidelines. 
• Monitors for protocol compliance to include but not limited to dosing, study procedures, assessment entries, and study patient documents to identify protocol non-compliance.
• Advises supervisor of any protocol deviations.
• Performs auditing of investigator-initiated studies to determine if the study is in compliance with the Code of Federal Regulations (CFR) guidelines and internal standard operating policies and procedures.
• Performs routine and systematic internal audits of studies in preparation for the enhancement of data quality and in preparation of an external audit. May assist with training and preparing staff for National Cancer Institute (NCI) and Food and Drug Administration (FDA) audits.
• Compiles data and prepares study-specific reports of audit findings.
• Assists with Implementation of standard operating procedures for the Clinical Trials Office.
• Assists with the development of site-specific operational policies and procedures to ensure site compliance with CFR guidelines.
• May supervise office staff and provide training to Clinical Trials Office Staff.
• Performs various duties as needed to successfully fulfill the functions of the position.

 

Job Requirements

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Required Education: Bachelor’s degree AND:

• 24 months working in a clinical trial data management or regulatory compliance

Equivalent/Substitution: Will accept 48 months clinical trial data management or regulatory compliance experience in lieu of the Bachelor’s degree for a total of 72 months experience.

Skills:

• Knowledge of CFR guidelines and standard operating policies and procedures
•  Must be able to develop and maintain constructive and cooperative working relationships with staff and outside entities Proficiency with Microsoft Office Suite, particularly Word and Outlook
• Ability to recognize protocol problems and discuss with supervisor 
• Ability to work as a team player
• Ability to communicate verbally and in writing

Working Conditions:

• Physical: Ability to engage in repetitive motion. Must be able to sit for prolonged periods of time.
• 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 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.

 
Hiring contingent upon a Background Check?: Yes
Special Indications: None 
Job Posting
: Jan 2, 2024