IRB Analyst 1

University System of Georgia; Georgia; On-site; USD 49,000 - 61,000; Full time

Job summary

Augusta University is seeking an IRB Analyst 1 to serve as the lead contact for IRB-related matters within the Social Behavioral IRB. The role involves coordinating agendas, triaging submissions, and ensuring accurate records and communication with investigators.

The ideal candidate will have a Bachelor’s degree in a related field and at least one year of IRB-related experience, with certification as an IRB professional preferred.

Qualifications

• Bachelor's degree in related field with 1 year of IRB-related experience
• Experience with ethics, clinical trials, or academic IRB preferred

Responsibilities

• Prepares meeting agenda in consultation with IRB Chair/Vice-Chair
• Assigns protocols to IRB members for review
• Attends convened IRB meetings and records thorough notes
• Prepares complete and accurate minutes of IRB meetings
• Maintains IRB minutes, rosters, files and regulatory documents
• Triages IRB submissions to determine need for full board review or expedited review
• Communicates IRB actions to investigators within required timeframes
• Works with researchers and staff to resolve issues related to IRB reviews
• Maintains all IRB files in compliance with regulations and policies

Skills

Regulatory knowledge

Interpersonal skills

Microsoft Office

Confidentiality

Teamwork

Education

Bachelor's degree in related field

Tools

Microsoft Office

Job description

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 12,000 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 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.

Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912

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 Analyst 1 will serve as the lead contact for IRB-related issues for the Social Behavioral IRB.

Responsibilities

• PREPARES MEETING AGENDA
• In consultation with the IRB Chair/Vice-Chair, prepares meeting agendas.
• Assigns scientifically appropriate protocols to IRB members for review.
• Attends convened meetings of the IRB.
• Maintains thorough and complete notes on discussions.
• PREPARES COMPLETE AND ACCURATE MINUTES OF THE MEETINGS
• Prepares complete and accurate minutes of IRB meetings, including attendance, actions taken, the basis for those actions, the basis for requiring changes in or disapproving research, and a written summary of controversial issues and their resolution.
• MAINTAINS MINUTES, IRB ROSTERS, IRB FILES
• Maintains minutes, IRB rosters, IRB hard copy and electronic files, and all other required regulatory documents in compliance with federal regulations, institutional policies, and IRB SOPs.
• TRIAGES IRB SUBMISSIONS
• Triages IRB submissions to determine whether the action requires full board review or if it meets the criteria for expedited procedural timeframe.
• Prepares written communication of all IRB actions to investigators within the required procedural timeframe.
• WORKS WITH RESEARCHERS AND RESEARCH STAFF
• Works with researchers and research staff to resolve issues related to convened IRB or expedited IRB review.
• MAINTAINS ALL IRB FILES
• Maintains all IRB files in accordance with Federal and State regulations and institutional policies within procedural timeframe.
• OTHER DUTIES
• Performs all other related duties as assigned.

Required Qualifications

Bachelor's degree from an Accredited College or university in a related field with one year of experience and knowledge directly related to IRB issues and human research protections (typical experience might include ethics, clinical trial performance, or experience in an academic IRB).

Preferred Qualifications

Certification as an IRB professional.

Knowledge, Skills, & Abilities

ABILITIES

• Detailed knowledge of applicable regulations related to the IRB
• Excellent interpersonal, written and verbal communication skills
• Proficient in Microsoft Office and other computer software/databases
• Ability to maintain confidentiality, function independently and as a team member
• Detail-oriented with strong planning, organization, negotiation and team building skills
• Ability to establish rapport and trust with research team members including physicians, nurses, and other staff and faculty
• Thorough knowledge of human subject research including federal, state and institutional policies, procedures, regulations and guidance to fully protect human subjects and/or human derived materials such as tissues, cells, medical records, etc.

Shift/Salary/Benefits

Shift: Days; M-F (Work outside of normal business hours may be required)

Pay Band: B9

Salary: $48,800.00/Annually-$61,000.00/Annually

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.

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.

Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.