IRB Coordinator

* 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 than12,000 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 iscreating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values 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 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 Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at . Location Augusta University- Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912 Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904 Job Summary Job Refresh The primary responsibility for review and approval of social-behavioral human research applications from AU researchers and student researchers as well as investigators for IRB for oversight. This position will ensure that submissions are accurate and complete and that regulatory guidance and human subjects align with regulations and policy. Responsibilities The duties include, but are not limited to: INTAKE ASSESSMENT AND INDEPENDENT DESIGNATED REVIEWER: Review exempt-category and social-behavioral expedited-category applications and render decisions for approval or modification. Review and approve modifications to approved projects, as permitted by regulations. Review reportable events and make appropriate decisions. Make Not Human Subjects Research determinations. Connect with the researcher/study researchers to acquire the needed information. Serve as liaison for the enterprise HRPP program to support the Community Engagement and Outreach Unit by partnering with various campus communities. Raise awareness to ensure submissions meet regulatory and human subjects' compliance requirements and offer tools to ensure human subjects' compliance adherence. Facilitate in-person and online forums and participate in class lectures to establish rapport and build communication. Manage Student Support Drop-In Hours for Summerville Campus. Host Monthly Lunch and Learns with Summerville Campus. GUIDANCE DOCUMENT MAINTENANCE: Work with units to develop and maintain application forms, processes, policies, and procedures to ensure compliance with the review of research protocols, as well as guidance and instruction for IRB and Investigators. Regularly audits and refines SOPs, guidance, and resources for researchers and reviewers. IRB COMMITTEE B, SOCIAL, AND BEHAVIORAL COORDINATION: Conduct a pre-review analysis of IRB submissions to ensure applications are adequately prepared and to identify any missing information that would preclude the ability to conduct an adequate review. Manage IRB Social and Behavioral IRB operations, including meeting management and pre- and post-meeting activities. Process response approvals for IRB B research applications that received modifications requiring a determination. Maintain appropriate documentation and reporting of review, study status, and panel activities. Create federally mandated institutional records in the form of meeting minutes that summarize the discussions and deliberations of the IRB in conformance with regulatory agency standards. Consult with the IRB Training Coordinator/IRB Education and Quality Coordinator to develop educational resources. HUMAN RESEARCH PROTECTIONS LIAISON: Advise investigators regarding federal and university policies regarding human research. In conjunction with the IRB Training Coordinator, provide training to the Summerville campus on IRB processes and federal regulations. Serve as a resource for investigators, research personnel, students, student researchers, and staff. OTHER : Perform other duties as assigned. Required Qualifications Bachelor's degree from an accredited college or university in a related field and a minimum of three years of experience and knowledge directly related to IRB operations and human research protections including ethics, clinical trial performance, or in an academic IRB. Preferred Qualifications Certification as an IRB professional is highly desirable OR the ability to obtain within 2 years. Certification as a Certified Clinical Research Coordinator or Certified Clinical Research Associate highly desirable. Knowledge, Skills, & Abilities KNOWLEDGE Proficient in Microsoft Office and other computer software/databases. SKILLS Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong prioritization and organizational skills. Demonstrated skill in running effective meetings. ABILITIES Ability to maintain confidentiality. Ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50/56, HIPPA Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and the AU IRB Policies and Procedures. Ability to exercise creativity in solving problems effectively while employing good judgment. Seeks opportunities to enhance professional advancement. Demonstrated ability to work independently with minimal supervision. Ability to function in a team environment. Shift/Salary/Benefits Shift: Days; M-F (Work outside of the standard business hours may be required) 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. Consider applying with us today! Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle. For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation. All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond. Other Information This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success." Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited. Equal Employment Opportunity Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans. How To Apply Consider applying with us today! Applicants are encouraged to tailor their resumes to the position of interest by clearly highlighting relevant work experience and skills gained from previous employment. Resumes should reflect how your background aligns with the qualifications and responsibilities of the role. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university Select University Faculty & Staff > Internal Applicants if you are a current university employee If you need further assistance, please contact us at View phone number on click.appcast.io