Research Compliance Auditor

The University of Arizona•Tucson, AZ

1d•Onsite

About The Position

The Human Subjects Protection Program (HSPP) provides administrative and regulatory support to the University of Arizona Institutional Review Board (IRB). Through collaboration with the research community, the HSPP promotes ethical and compliant human research. The HSPP is seeking a Research Compliance Auditor who will primarily conduct routine audits of research protocols for adherence to federal, state and institutional policy. The Research Compliance Auditor will collaborate with the Quality Assurance officer and a varied group of auditors across multiple departments to ensure a broad cross-section of research projects are reviewed. They will identify mitigation strategies through analysis of corrective actions which increase adherence to policy, and are identified by compliance committees in the research division. The Research Compliance Auditor will assist with development of tools and resources to assist investigators regarding compliance to regulatory requirements. The Research Compliance Auditor will assist the AVP Regulatory Affairs with investigations on other research integrity matters.

Requirements

Bachelor's degree or equivalent advanced learning attained through professional level experience.
Minimum of 3 years of relevant work experience.
Knowledge of research protocol design in healthcare disciplines.
Knowledge and skills in policy development, review, and implementation.
Ability to demonstrate clear and concise communication.

Responsibilities

Conduct regulatory audits to ensure compliance with and responses to post-approval monitoring activity.
Write audit reports, and be responsible to review plans that monitor and correct deficiencies.
Partner with the Quality Assurance Officer to ensure corrective actions are actionable and consistent with institutional policy, regulatory requirements, and best practice.
Develop tools and resources related to regulatory submissions to federal agencies, best practices for items such as monitoring research programs, good documentation and laboratory practices, and auditing tools. Resources will target compliance risks and mitigation strategies to reduce risks.
Collaborate with the training and regulatory programs in RII to develop resources and participate in trainings on developing areas of concern.
Create high level reports and collaborate with senior management on policy changes.
Provide technical, regulatory advice and training that improves adherence to regulatory requirements.
Assist the AVP Regulatory Affairs/Integrity by serving as an independent representative on complex regulatory and research misconduct allegations.
Assist with writing reports of outcomes of the inquiry and investigations and reporting to federal, state and institutional offices.