*Lead 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 Lead Clinical Trials Compliance Specialist performs quality management of site-specific and affiliate Clinical Trials and investigator-initiated studies, oversees protocol compliance and discusses protocol deviations with management, prepares staff for external audits, implements standard operating procedures and performs training and education for Clinical Trials Office Staff.

Duties:

• Quality Management.  Performs Quality Management of site-specific and affiliate Clinical Trials in compliance with federal, sponsor, and internal guidelines. Reviews for protocol compliance and develops action plans to address the deficiencies as needed. Discusses protocol deviations with appropriate Clinical Trials staff and management. Formulates and recommends appropriate process changes to enhance data quality.
• Institutional Studies.  Performs Quality Management of investigator-initiated studies in compliance with the Code of Federal Regulations (CFR) guidelines and internal standard operating policies and procedures.
• External Audits.  Performs systematic internal review of studies in preparation for external audits.  Trains and prepares staff for NCI audits and FDA inspections.  Coordinates preparation for audits with physicians, data management, pharmacy, and research nurses.  Ensures that data is ready for auditors and works directly with staff and physicians to resolve outstanding clinical or data entry issues. 
• Procedures.  Implements standard operating procedures for the Clinical Trials Office. Develops site-specific operational policies and procedures to ensure site compliance with CFR guidelines.
• Training.  Performs training and educational programs to ensure Clinical Trials Office staff are trained in compliance with CFR quality guidelines.
• Site Audit Coordinator.  Represents the site as point-of-contact for external auditors in all NCI audit and FDA inspection activities.  Oversees data preparation for site audits. 
• Supervision.  Supervises compliance staff to include hiring, training, evaluating, reprimanding, and terminating employees.  Recommends salary increases and promotions to management.
• Evaluation.  Evaluates recommendations and action plans from external audits and is responsible to make changes recommended by the audits.  Collaborates with other departments, physicians, and principal investigators to implement the recommended changes.  Updates the standard operating policies and procedures if needed.
• Reports.  Prepares study-specific reports of audit findings and discusses with management.
• As Needed.  Performs other duties as assigned by the supervisor.

Education: Bachelor's degree AND:

• 36 months experience in 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 84 months experience.

Skills:

• Advanced knowledge of clinic audit procedures.
• Ability to communicate effectively.
• Ability to identify protocol problems, analyze information, and evaluate results to solve problems.
• Ability to develop constructive and cooperative working relationships with staff and outside entities.
• Ability to multitask.
• Ability work as a team player and work independently.
• Ability to supervise.

Working Conditions:

• Physical:  Ability to engage in repetitive motions. 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.