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

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.