Research Compliance Administrator IV, Research Office (College of Medicine, Phoenix)

The Clinical Research Compliance Team is a functional component of the Research Office's centralized clinical research unit that is organized to provide support for new and ongoing efforts in clinical research at the College of Medicine Phoenix. The Compliance Team provides quality assurance/quality control monitoring of ongoing clinical research and provides training to ensure safety and compliance in research conduct.

This Research Compliance Administrator IV position will provide high-level dedicated administrative support and training to research investigators and staff to ensure compliance with federal, state, and local regulatory requirements for conducting clinical trials. It is expected that this person will have extensive knowledge of clinical research practices, IRB policies, monitoring/auditing processes, and regulatory requirements.

• Visa sponsorship is available for this position.

Outstanding U of A 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! Outstanding U of A 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!

The University of Arizona has been recognized for our innovative work-life programs. For more information about working at the University of Arizona and relocation services, please click here.

Clinical Trials Compliance Oversight:

• Work independently, utilizing expert knowledge of research compliance to review adherence to complex protocols for device and drug trials that require fast-paced processing and unique and innovative solutions to maintain compliance.
• Lead regulatory review activities across multiple departments relating to clinical trial conduct for the study lifecycle. Prepare, conduct, and report study compliance audits across clinical trials.
• Prepare and coordinate submission of new INDs/IDEs (drug/device, industry sponsored, investigator-initiated, national cooperative group) for approval on internal and other committee reviews, conflict of interest (COI) and IRB reviews, and other regulatory agency reviews. generate IRB-approved study reports and provide metrics on PIs and study volumes for the college.
• Serve as content expert for institutional processes and OHRP federal agency policies and FDA regulations to ensure accurate oversight of FDA regulated clinical trials and investigator-initiated studies.

Training:

• Ensure compliance training for faculty, staff, students, and study teams, developing ongoing educational content and ensuring adherence to regulatory requirements.
• Serve as an expert and primary resource to multiple investigators for Human Subjects and Conflict of Interest requirements and reporting and adherence to COI management plans and IRB guidance.
• Maintain close communication with site staff to assure adherence to protocol and regulatory guidelines and resolve problems.

Leadership:

• Collaborate with college clinical and research leadership to promote ongoing education of human subjects' protection requirements and changes in processes to ensure ongoing regulatory compliance.
• Serve as content expert for college and university committees that pertain to human subject protections.
• Elevate concerns and make recommendations for improvement of compliance measures to leadership.
• Participate in protocol development stages to provide high level regulatory compliance guidance across multiple departments to ensure proposed projects consider human safety assurances and regulatory components.
• Participate in strategic initiatives that affect college and institutional practices concerning human subjects safety and monitoring.
• Serve as content expert in navigating college and university regulatory systems (Research intake, tracking, COI, IRB, etc).

Mentoring:

• Maintain thorough understanding of current human subjects regulations and applicable regulatory requirements and guidelines.
• Serve as an expert and primary resource for answering role-related questions and compliance processes across departments.
• Utilize depth of professional knowledge and experience to mentor and lead new staff for regulatory compliance knowledge and processes.

Knowledge, Skills & Abilities:

• Ability to effectively utilize computer applications, internet resources, and Microsoft Office programs, including Outlook, Word, and Excel.
• Strong organizational, administrative, communication, and interpersonal skills required.

This job posting reflects the general nature and level of work expected of the selected candidate(s). It is not intended to be an exhaustive list of all duties and responsibilities. The institution reserves the right to amend or update this description as organizational priorities and institutional needs evolve.

• Bachelor's degree or equivalent advanced learning attained through professional level experience required.
• Eight (8) years of relevant work experience, or equivalent combination of education and work experience.

• Master's degree in a related field of study.
• Research experience.
• Experience working in a Clinical Trial Office at an Academic Center.

Office of Talent Acquisition

talent@arizona.edu

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

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