"Regulatory Compliance & Quality Specialist - Institutional Review Board"

Job Summary

The Regulatory Compliance and Quality Specialist will collaborate with AU HRPP leadership in the development and implementation of the HRPP internal quality improvement and assurance program. The Quality Assurance Specialist will conduct audits of investigators and the AU IRBs, as required by the office's internal QA/QI program to ensure compliance with federal regulations, institutional policies, and other agency requirements governing human subject research. The position is the lead auditor for studies approved under a reliance agreement in which AU relies on another IRB or an AU IRB serve as reviewing IRB for multi-site studies, to include those under the NIH single IRB (sIRB) mandate. The Regulatory and Quality Specialist serves as the lead advisor to the IRBs providing regulatory guidance and support.

Responsibilities

Responsibilities to include, but are not limited to:

• AUDITING: Conduct audits of human research activities of researchers and the IRB.
• QUALITY ASSURANCE PROCESSES: Serve as lead of quality assurance monitoring processes of the AU IRB submissions to ensure compliance with AU IRB policies, institutional policies and regulatory requirements. Assist with preparation for site visits from external entities (ie: FDA, AAHRPP, etc.)
• METRICS & REPORTING: Develop and maintain reporting and metrics for the IRB Office to include QA findings, AAHRPP required reporting, audit trends, consultations, etc. This includes identifying trends and developing trainings in conjunction with the IRB Office Training Coordinator.
• CONSULTATIONS: Serve as lead compliance consultant for the IRB Office Consultation services.
• OTHER: Perform other related duties as assigned.

Required Qualifications

Bachelor's degree from an accredited college or university with three years' relevant experience in administration of IRB and/or clinical trials or research administration. Certified IRB Professional (CIP) or comparable certification required (CRA, CCRC, CCRP, CHRC, etc.), or the ability to obtain certification within three years of employment.

Preferred Qualifications

Certified IRB Professional (CIP) or comparable certification. Experience developing and/or implementing Corrective Action Preventive Action (CAPA) plans in relation to patient safety, compliance, monitoring, or auditing.

Knowledge, Skills, & Abilities

KNOWLEDGE
Demonstrated knowledge of federal, state, local regulations and in-depth understanding of ethical principles regarding the conduct of research and regulatory issues involving protection of human subjects in research. Knowledge of the scientific research process in both biomedical and behavioral fields.

SKILLS
Critical review and auditing skills. Demonstrate excellent interpersonal, analytic skills. Excellent communication skills, written and oral, including public speaking. Cooperative and positive attitude including demonstrated team building skills. Skilled in working in an all-electronic environment including expertise with Microsoft Office, DocuSign, Adobe, and other computer software/databases.

ABILITIES
Ability to maintain confidentiality. Ability to establish rapport and trust with the research community to include physicians, nurses, students, faculty, and staff. Ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and the AU IRB Policies and procedures. Ability to manage multiple projects at once with a high level of accuracy and attention to detail. Ability to work independently to meet stated objectives with minimal supervision. Accepts and adapts to changes in office procedures or priorities.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $68,500-$71,734.30 annually. Pay Band: B13. Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position. Recruitment Period: Until Filled. Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees. Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays. Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program.

Our mission and values. The University System of Georgia. USG Statement of Core Values and Code of Conduct. Freedom of Expression as stated in Board Policy 6.5.