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.).