*Clinical Trials Compliance Specialist at University of Oklahoma in Oklahoma City, Oklahoma

Job Description:

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 Clinical Trials Compliance Specialist, under direct supervision, performs auditing of site-specific and affiliate clinical trials and investigator-initiated studies and monitors protocol compliance.

Learn more about the Stephenson Cancer Center’s Clinical Trials Office here.

Duties:

• Performs routine 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.


• Assists with compiling data and preparing study‐specific reports of audit findings. Performs related duties as assigned to successfully fulfill the functions of the position.

Required Education: High School Diploma AND:

• 12 months working in a clinic or with clinical trials experience

Skills:

• 
  Basic 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: Must be able to sit for prolonged periods of time. Reaching, bending, and speaking. Manual dexterity.


• 
  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.

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