IRB Coordinator

Augusta University

Augusta, GA

Job posting number: #7293993 (Ref:ej-5812555)

Posted: November 18, 2024

Job Description


IRB Coordinator
Job ID: 279194
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 Coordinator will provide regulatory expertise, guidance and administrative support to the Internal Institutional Review Boards (IRBs) Biomedical I (IRB A), Social Behavioral (IRB B) and Biomedical II (IRB C) to include reviewing greater than minimal risk human subject research protocols. The IRB Coordinator will attain and maintain comprehensive and up-to-date knowledge of human subject research protections and IRB regulations as contained in 45 CFR 46, 21 CFR 50 & 52, and other applicable regulations.
Responsibilities
The duties include, but are not limited to:
MEETING COORDINATOR FOR INTERNAL IRB
Conducts analysis of greater than minimal risk submissions; Consults with IRB reviewers and researchers to ensure the greater than minimal risk submission is complete and ready for convened IRB review; In consultation with the Outreach and Training Specialist , identifies and coordinates the training and education needs of IRB members; Coordinate the monthly IRB (A, Band C) agenda for each meeting and ensure that materials are distributed within established guidelines; Facilitate monthly IRB (A, Band C) meetings and Ad Hoc meetings as needed, record deliberations, and write meeting minutes for each IRB. Ensure that minutes for each meeting are accurately recorded; finalize minutes for IRB Chair approval and filing; Coordinate the monthly agendas for each meeting and ensure that materials are distributed within established guidelines; Compose letters that accurately document the determinations of the IRB and describe any revisions required by the research team.
Assist in developing, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions; Maintain IRB-required record keeping and prepare correspondence to AU investigators, study sponsors, and regulatory agencies that document the determinations of the IRB; In conjunction with the IRB Training Coordinator , develop and implement education sessions on topics related to human subjects research protections to AU researchers and IRB members.
IRB MEETING ROLES
Serve as voting IRB Member and designated reviewer.
DAILY OPERATIONAL SUPPORT OF IRB
Serves as Lead on IRB Mail Triage to ensure submissions are triaged to the appropriate IRB; Assists with updates to IRB Operations intake checklist and IRB Operations SOPs; Serves as back-up support for the Assistant Director of IRB Operations in their absence.
QUALITY ASSURANCE REVIEWS
Participate in internal quality assurance reviews and assessments of minimal risk study submissions.
OTHER
Perform all other related 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 ability to obtain certification within 2 years.
Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases.
SKILLS
Excellent interpersonal, written, and verbal communication skills. Strong analytic skills and organization skills.
ABILITIES
Ability to maintain confidentiality and function in a team environment. Demonstrated ability to lead effective meetings. Seeks opportunities to enhance professional advancement. Demonstrated ability to work independently with minimal supervision. Ability to exercise creativity in solving problems effectively while employing good judgment.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Pay Band: B10
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: 279194.
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=279194&PostingSeq=1
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Job posting number:#7293993 (Ref:ej-5812555)
Application Deadline:Open Until Filled
Employer Location:Augusta University
Augusta,Georgia
United States
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