IRB Operations Manager
Job ID: 279612
Location: Augusta University
Full/Part Time: Full Time
Regular/Temporary:
*

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/welcome_to_the_board_of_regents_university_system_office 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/#p8.2.18_personnel_conduct.
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.
Location
Augusta University-
Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904
College/Department Information
The Institutional Review Board Office ensures the research goals of the Augusta University enterprise are met, while protecting human subjects involved in research and verifying the enterprise meets compliance standards. The IRB Office also serves as the central contact for facilitating the goals of the Enterprise Human Research Protection Program (HRPP). Our office provides: Administrative support for the internal IRBs and a liaison for the external IRBs; Monitoring and oversight for all IRB approved studies; Education and training for human research investigators, staff, and IRB members.
Job Summary
The IRB Operations Manager will be responsible for providing day-to-day technical and functional expertise in the area of human research protections for all Institutional Review Boards for AU. This position will oversee the monthly IRB Meetings to ensure continued compliance. The position will manage IRB electronic submission systems and provide guidance and direction to the IRB Operations support staff. This position will be responsible for maintenance of IRB Rosters, IRB Registrations, and the IRB FWA number. The position will maintain updated policies, guidance and SOPs as related to IRB Operations. This position will aide in AAHRPP Accreditation activities and should maintain knowledge of all major activities of the Human Research Protections Office (HRPP) and respond to inquiries from faculty, staff, and students directly or to other HRPP personnel.
Responsibilities
Responsibilities to include but not limited to:
Responsible for the strategic day to day leadership of the IRB Operations support staff to include: Supervising and mentoring employees; Set standards and role model effective presentation and discussion for all Board members; Training and development of new IRB Operations Staff; Oversee the monthly IRB Meetings to ensure continued compliance; Providing oversight for IRB Operations work process flow and continuous improvement; Monitor IRB metrics and utilize data to ensure compliance and increase efficiency; Maintain and update IRB rosters, IRB Registrations, and IRB FWA Number with all applicable regulatory agencies. Serve as an expert liaison between the research investigator and the IRB reviewer; educate parties on relevant and emerging regulations and related risk management issues. Provided training and consultation to the research community regarding Internal research and processes.
Supports the Institutional Official and the IRB with IRB member selection, Member Onboarding and Appointment according to IRB policy. Coordinate and implement the annual IRB Member Evaluation and Re-Appointment process and annual IRB Member Self Assessments.
Provides assistance to IRB Leadership in preparation for AAHRPP accreditation and in various compliance and quality assurance activities.
Maintains updated information on federal, state, and local regulations, inspections, policies and procedures and other resources that directly impact IRB activities, to ensure satisfactory compliance. Responsible for communication and dissemination of information regarding regulatory activities associated with Internal IRB studies.
Reviews each IRB's agenda and minutes to ensure compliance with state laws, federal regulations, VA regulations, and AAHRPP standards.
Serves as a designated IRB Reviewer for exempt and expedited submissions.
Perform other duties as assigned.
Required Qualifications
Bachelor's degree from an accredited college or university and with 5 years' experience working in an IRB Office AND previous experience with writing policies, SOPs, and guidance documents, knowledge of Human Subject Research federal regulations, and experience in developing educational presentation/public speaking.
Preferred Qualifications
Preferred Educational Qualifications
Master's degree from an accredited college or university; Certification as a Certified IRB Professional (CIP) or the ability to obtain the certification within two years of employment. Membership in national or regional human subjects organization is preferred.
Preferred Experience
Experience with clinical trials, general research and IRB Operations.
Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases.
Knowledge of IRB operations, electronic IRB submission system and the operation of clinical departments and/or clinical research projects.
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong organizational and prioritization skills.
ABILITIES
Ability to maintain confidentiality and vital institutional records.
Ability to document actions, conversations, etc. without decreasing work flow.
Shift/Salary/Benefits
Shift: Days/M-F (Work outside of normal business hours may be required).
Pay Band: B14
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!
https://www.augusta.edu/hr/jobs/ Search for Job ID:
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 706-721-9365.
To apply, visit https://careers.hprod.onehcm.usg.edu/psp/careers/CAREERS/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=12000&JobOpeningId=279612&PostingSeq=1
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