Research Compliance Administrator III, Department of Internal Medicine (Phoenix)

This Research Compliance Administrator III position will provide dedicated administrative support and training to research investigators and staff to ensure compliance to regulatory requirements for conducting clinical trials. It is expected that this person will have knowledge regarding clinical research practices, monitoring/auditing processes, and regulatory requirements.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; state retirement plan; access to UA recreation and cultural activities; and more!

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• Coordinates and conducts monitoring and auditing to ensure compliance with policies, regulations, protocols and SOPs.
• Review and track regulatory documentation.
• Monitors and inspects facilities and research conditions to determine health hazards, and recommends corrective or preventative actions.
• Conduct clinical study monitoring, ensuring compliance with the protocol, Code of Federal Regulations/International Conference of Harmonization/Good Clinical Practices (CFR/ICH/GCP) guidelines, local regulations and applicable Standard Operating Procedures (SOPs).
• Review source documents and case report forms for clarity, consistency and accuracy.
• Develop and/or advise on research compliance procedures, processes, and policies (i.e. SOPs, policies, CAPA plans).
• Provides technical and regulatory advice and training in the areas of research compliance and safety.
• Advises Pl and study team on compliance, safety and regulatory components during proposals/protocol development.
• Prepare, coordinate and maintain regulatory compliance and related documentation required by compliance departments, regulatory agencies or sponsors.
• Assist to prepare and/or coordinate protocol reviews (includes new protocol developments, IND/IDE, IRB, sponsoring agency compliance review and other regulatory agency reviews).
• Works with federal and state officers of administration and staff to ensure uniformity of review and compliance with standard operating procedures and applicable federal and state regulations.
• May review correspondence and conduct quality improvement initiatives.
• Monitor close communication with site staff to assure adherence to protocol and regulatory guidelines and resolve problems timely.
• Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
• Serve as a role expert and as a primary resource for answering role related and compliance process related questions.
• Maintain up to date site research activity date for metrics reporting utilizing internal and institutional databases.

Knowledge, Skills, and Abilities:

• Strong organizational, administrative, communication, and interpersonal skills.
• Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.).

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Five (5) years of relevant work experience, or equivalent combination of education and work experience.

College of Medicine-Phoenix, Office of Human Resources

HR-PHX@arizona.edu

Application: The online application should be completed in its entirety. Blank or missed information may be considered an incomplete submission.

Letter of Interest: Should clearly indicate how your skills and professional employment experience meet the Minimum and the Preferred qualifications (if applicable).