Clinical Trials Compliance Manager

Pay Competitive

Employment type

Full-Time

Req#: 359941 !*!

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 Clinical Trials Compliance Manager is responsible for all auditing of site-specific and affiliate clinical trials and investigator-initiated studies to ensure compliance with federal, sponsor, and internal guidelines. This position monitors protocol compliance and discusses with management protocol deviations and recommends appropriate process changes to enhance data quality.

The Clinical Trials Compliance Manager collaborates with informatics and Database Analyst to ensure compliance with Health Insurance Portability and Accountability Act (HIPAA) requirements.

Duties:

• Responsible for all auditing of site-specific and affiliate clinical trials in compliance with federal, sponsor, and internal guidelines
• Develops and implements site auditing and informatics Standard Operating Procedures (SOPs) and provides critical input
• Monitors for protocol compliance to include but not limited to dosing, study procedures, assessment entries, study patient documents to identify protocol non-compliance, and develops action plans to address the deficiencies
• Discusses protocol deviations with appropriate Clinical Trials staff and management
• Formulates and recommends appropriate process changes to enhance data quality
• Ensures Clinical Trials Office (CTO) informatics and databases are compliant with HIPAA requirements
• Performs auditing of investigator-initiated studies in compliance with the Code of Federal Regulations (CFR) guidelines and internal standard operating policies and procedures
• Represents the site as point-of-contact for external auditors in all external auditing activities
• Performs systematic internal audits of studies in preparation for the enhancement of data quality and in preparation for external audits
• Trains and prepares staff for external audits
• 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
• Implements standard operating policies and procedures for research record organization and storage
• Develops site- specific operational policies and procedures to ensure site compliance with CFR guidelines
• Performs training and educational programs to ensure clinical research staff are trained in compliance with CFR quality guidelines
• Supervises auditing and informatics staff to include hiring, training, evaluating, reprimanding, and terminating employees
• 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
• Prepares study-specific reports of audit findings and discusses with management and other staff
• Performs various duties as needed to successfully fulfill the function of the position
!*!

Education: Bachelor’s Degree

Experience: 60 months experience in clinical trial data management or regulatory compliance.

Equivalency/Substitution: Will accept 48 months clinical trial data management or regulatory compliance experience in lieu of the Bachelor’s Degree for a total of 108 months experience. Master’s Degree and 36 months clinical trial data management or regulatory compliance 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…