Research Compliance Administrator II, Office of Research (College of Medicine-Phoenix)

Clinical Trial Start Up: Work independently to support the regulatory packet submission of new protocols (drug/device, industry sponsored, investigator-initiated, national cooperative group) across multiple departments for regulatory review and approval from intake of regulatory packet through hospital feasibility and IRB approvals. Prepare and coordinate submission requests for study protocol amendments and revisions and annual IRB reviews as required by regulations. Coordinate regulatory activities relating to clinical trial start up and study conduct for the duration of the study. Regulatory Maintenance: Prepare and maintain regulatory documentation binders for internal and externally sponsored clinical studies as required by IRB, regulatory bodies and sponsors including IRB approvals, amendments, sponsor and regulatory communications. Maintain continuous communication with study teams to ensure research compliance and documentation throughout study duration and resolve problems timely. Update and maintain clinical trial management system with study status and regulatory documentation. Assist/Conduct study initiation, interim monitoring and close-out visits for Investigator-initiated clinical research trials. Training and Support: Deliver technical and regulatory guidance, including individual and group trainings, to investigators and study staff on research compliance and regulatory requirements across multiple departments. Support monitoring and auditing activities to ensure compliance to policies, regulatory requirements, study protocols, and standard operating procedures (SOPs), as needed. Serve as a liaison for answering role related and compliance process related questions. Mentor clinical research coordinators and compliance peers on regulatory requirements and process timelines. Help train new coordinators and entry level compliance admins as needed. Improvement: Participate in the development and implementation of compliance processes and procedures, as needed. Contribute insights on department specific research initiatives that affect the college’s regulatory processes and requirements. Knowledge, Skills, and Abilities: Strong organizational, administrative, communication, and interpersonal skills required. Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.).