Research Compliance Auditor: Policy & Audit Lead

Phase2 Technology; Tucson (AZ); On-site; USD 53,000 - 66,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability benefits

Paid leave

Tuition reduction

Retirement plans

Job summary

The University of Arizona is seeking a Research Compliance Auditor within the Human Subjects Protection Program (HSPP) to audit research protocols for adherence to federal, state and institutional policies.

You will collaborate with Quality Assurance and other auditors, develop tools for regulatory submissions, and help investigators understand regulatory requirements while supporting investigations led by the AVP Regulatory Affairs.

Qualifications

• 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.
• 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.

Skills

Research protocols

Policy development

Clear communication

Education

Bachelor's degree

Job description

The University of Arizona is seeking a Research Compliance Auditor within the Human Subjects Protection Program (HSPP) to audit research protocols for adherence to federal, state and institutional policies.

You will collaborate with Quality Assurance and other auditors, develop tools for regulatory submissions, and help investigators understand regulatory requirements while supporting investigations led by the AVP Regulatory Affairs.