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

The University of Arizona•Phoenix, AZ

About The Position

The Research Compliance Administrator IV works on the Clinical Research Compliance Team, a component of the Research Office’s centralized clinical research unit at the College of Medicine–Phoenix. The position provides high-level administrative support and training to research investigators and staff to help ensure clinical trials comply with federal, state, and local regulatory requirements. The role calls for extensive knowledge of clinical research practices, IRB policies, monitoring and auditing processes, and regulatory requirements. The administrator independently oversees compliance for complex drug and device trials, leads regulatory review activities across departments, conducts and reports study audits, and coordinates regulatory submissions. The role also develops and delivers compliance training, advises investigators and study teams on human-subjects and conflict-of-interest requirements, collaborates with college and university leadership and committees, and mentors staff on regulatory compliance processes. Visa sponsorship is available.

Requirements

Bachelor’s degree or equivalent advanced learning attained through professional-level experience.
Eight years of relevant work experience, or an equivalent combination of education and work experience.
Extensive knowledge of clinical research practices, IRB policies, monitoring and auditing processes, and regulatory requirements.
Ability to effectively use computer applications, internet resources, and Microsoft Office programs, including Outlook, Word, and Excel.
Strong organizational, administrative, communication, and interpersonal skills.

Nice To Haves

Master’s degree in a related field of study.
Research experience.
Experience working in a Clinical Trial Office at an academic center.

Responsibilities

Review adherence to complex drug and device trial protocols and develop solutions to maintain compliance.
Lead regulatory review activities across multiple departments throughout the clinical trial lifecycle.
Prepare, conduct, and report compliance audits across clinical trials.
Prepare and coordinate submissions for new INDs and IDEs for internal and other committee, COI, IRB, and regulatory agency review.
Generate IRB-approved study reports and provide metrics on principal investigators and study volumes for the college.
Provide expert oversight on institutional processes, OHRP policies, and FDA regulations for FDA-regulated trials and investigator-initiated studies.
Ensure compliance training for faculty, staff, students, and study teams; develop ongoing educational content.
Advise investigators on human-subjects and conflict-of-interest requirements, reporting, COI management plans, and IRB guidance.
Communicate with site staff to support protocol and regulatory adherence and resolve problems.
Collaborate with clinical and research leadership to promote education on human-subject protections and process changes.
Serve as a content expert for college and university committees concerning human-subject protections.
Escalate compliance concerns and recommend improvements to leadership.
Provide regulatory guidance during protocol development across departments.
Participate in strategic initiatives concerning human-subject safety and monitoring.
Guide users through college and university regulatory systems, including research intake, tracking, COI, and IRB processes.
Maintain knowledge of current human-subject regulations and applicable requirements and guidelines.
Answer questions about role-related compliance processes across departments and mentor new staff.