ABOUT US

Augusta University is Georgia’s innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia’s cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia’s only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values https://www.augusta.edu/about/mission.php make Augusta University an institution like no other.
Augusta University’s distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state.
The University System of Georgia https://www.usg.edu/hr/orientation/welcometotheboardofregentsuniversitysystemoffice is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at https://www.usg.edu/policymanual/section8/C224/#p8.2.18personnelconduct.
Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at https://www.usg.edu/policymanual/section6/C2653.

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.

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. Experience with quality assurance monitoring or auditing.
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

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 rese
arch.
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.

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.