Sr. Clinical Trials Compliance Specialist

University of Oklahoma

Oklahoma, OK

ID: 7110034 (Ref.No. ta222491)
Posted: September 8, 2022
Application Deadline: Open Until Filled

Job Description

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OU Health Stephenson Cancer Center is Oklahoma’s only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 71 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.

Responsibilities:

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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Education: Bachelor’s Degree

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

Equivalency: 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& Abilities:

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

Equal Employment Opportunity Statement: The University of Oklahoma, 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, 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.

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.

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