IRB Reliance Manager
Apply NowCompany: Augusta University
Location: Augusta, GA 30906
Description:
*
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 Reliance Manager establishes and maintains relationships with institutional and non-AU key stakeholders to include external IRBs. The position assumes primary responsibility for overseeing the daily operations associated with externally reviewed protocols, studies in which AU relies on a non-AU IRB, and studies in which AU serves as the single IRB (slRB) of record. The position will maintain updated policies, guidance and SOPs as related to IRB External Relations. This position will oversee the IRB External support staff and assist with AAHRPP Reaccreditation.
In addition, this position will maintain and oversee the quality improvement and assurance metrics and work with the IRB Training Coordinator to develop needed training for the Human Research Protections (HRPP) staff, IRB and Investigators. This position will identify IRB quality-related workflow processes for inefficiencies and develop strategies for improvement. This position will also aid in AAHRPP Accreditation activities and should maintain knowledge of all major activities of the HRPP and respond to inquiries from faculty, staff, and students directly or to other HRPP personnel.
Responsibilities
Responsibilities to include but not limited to:
Provides assistance to IRB Leadership in preparation for AAHRPP accreditation and in various compliance and quality assurance activities.
Creates and provides reports to AU leadership regarding externally reviewed protocols.
Identifies, responds to, and participates in resolving potential and actual problems related to externally reviewed and slRB protocols.
Assesses and negotiates sponsor requested changes to AU informed consent boilerplate language to include the HIPAA Authorization, cost, injury, and payment language. Serves as the liaison with the AU Privacy Office.
Serves as a designated IRB Reviewer for exempt and expedited submissions.
Assumes primary responsibility for implementing and negotiating agreements (IAA'a, IIA's, MOU's) associated with collaborative research with non-AU entities.
Responsible for communication and dissemination of information regarding regulatory activities associated with slRB and external IRB studies.
Provides training and consultation to the research community regarding external IRB studies, slRB, and the reliance process.
Assists with AAHRPP Reaccreditation Activities.
Responsible for the analysis and assessment of reliance studies (when AU is the slRB and when AU relies on a non-AU IRB) and studies reviewed by a commercial IRB. Maintains updated policies, guidance and SOPs as related to IRB External research. Oversees the IRB External support staff to include training and development.
Responsible for maintaining quality improvement and assurance metrics and development of subsequent training for internal and external research studies. Identifies IRB quality-related workflow processes for inefficiencies and develops strategies for improvement.
Manages Charlie Norwood VA Medical Center (CNVAMC) protocols as the liaison for the AU IRB Office.
Other Duties as assigned.
Required Qualifications
Bachelor's degree from an accredited college or university and a minimum of three years of experience in IRB Human Research Protection and IRB Office Functioning.
Preferred Qualifications
Master's degree from an accredited college or university in Business, Healthcare, or Research Administration.
Certified IRB Professional or the ability to obtain CIP credentials within two years of employment.
Previous experience with writing policies, SOPs, and guidance documents, knowledge of Human Subject Research federal regulations, and experience in developing educational presentation/public speaking.
Knowledge, Skills, & Abilities
KNOWLEDGE
Proficient in Microsoft Office and other computer software/databases.
Demonstrates clear high-level knowledge and practice of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPPA regulations, Confidentiality Policy, and IRB policies related to human subject protection and clinical research in general.
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong organization and prioritization skills.
ABILITIES
Ability to maintain confidentiality.
Ability to write clear, precise, concise, and grammatically correct emails, memos, and technical reports.
Ability to quickly become proficient in the use of an on-line IRB submission system and a separate IRB reporting system.
Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary Range: $75,300-85,000 annually.
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: 283869.
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.
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 Reliance Manager establishes and maintains relationships with institutional and non-AU key stakeholders to include external IRBs. The position assumes primary responsibility for overseeing the daily operations associated with externally reviewed protocols, studies in which AU relies on a non-AU IRB, and studies in which AU serves as the single IRB (slRB) of record. The position will maintain updated policies, guidance and SOPs as related to IRB External Relations. This position will oversee the IRB External support staff and assist with AAHRPP Reaccreditation.
In addition, this position will maintain and oversee the quality improvement and assurance metrics and work with the IRB Training Coordinator to develop needed training for the Human Research Protections (HRPP) staff, IRB and Investigators. This position will identify IRB quality-related workflow processes for inefficiencies and develop strategies for improvement. This position will also aid in AAHRPP Accreditation activities and should maintain knowledge of all major activities of the HRPP and respond to inquiries from faculty, staff, and students directly or to other HRPP personnel.
Responsibilities
Responsibilities to include but not limited to:
Provides assistance to IRB Leadership in preparation for AAHRPP accreditation and in various compliance and quality assurance activities.
Creates and provides reports to AU leadership regarding externally reviewed protocols.
Identifies, responds to, and participates in resolving potential and actual problems related to externally reviewed and slRB protocols.
Assesses and negotiates sponsor requested changes to AU informed consent boilerplate language to include the HIPAA Authorization, cost, injury, and payment language. Serves as the liaison with the AU Privacy Office.
Serves as a designated IRB Reviewer for exempt and expedited submissions.
Assumes primary responsibility for implementing and negotiating agreements (IAA'a, IIA's, MOU's) associated with collaborative research with non-AU entities.
Responsible for communication and dissemination of information regarding regulatory activities associated with slRB and external IRB studies.
Provides training and consultation to the research community regarding external IRB studies, slRB, and the reliance process.
Assists with AAHRPP Reaccreditation Activities.
Responsible for the analysis and assessment of reliance studies (when AU is the slRB and when AU relies on a non-AU IRB) and studies reviewed by a commercial IRB. Maintains updated policies, guidance and SOPs as related to IRB External research. Oversees the IRB External support staff to include training and development.
Responsible for maintaining quality improvement and assurance metrics and development of subsequent training for internal and external research studies. Identifies IRB quality-related workflow processes for inefficiencies and develops strategies for improvement.
Manages Charlie Norwood VA Medical Center (CNVAMC) protocols as the liaison for the AU IRB Office.
Other Duties as assigned.
Required Qualifications
Bachelor's degree from an accredited college or university and a minimum of three years of experience in IRB Human Research Protection and IRB Office Functioning.
Preferred Qualifications
Master's degree from an accredited college or university in Business, Healthcare, or Research Administration.
Certified IRB Professional or the ability to obtain CIP credentials within two years of employment.
Previous experience with writing policies, SOPs, and guidance documents, knowledge of Human Subject Research federal regulations, and experience in developing educational presentation/public speaking.
Knowledge, Skills, & Abilities
KNOWLEDGE
Proficient in Microsoft Office and other computer software/databases.
Demonstrates clear high-level knowledge and practice of ICH/GCP guidelines, FDA regulations, OHRP regulations, HIPPA regulations, Confidentiality Policy, and IRB policies related to human subject protection and clinical research in general.
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong organization and prioritization skills.
ABILITIES
Ability to maintain confidentiality.
Ability to write clear, precise, concise, and grammatically correct emails, memos, and technical reports.
Ability to quickly become proficient in the use of an on-line IRB submission system and a separate IRB reporting system.
Ability to effectively communicate with researchers, research staff, and IRB members on matters of research compliance and ethical human research practices.
Shift/Salary/Benefits
Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary Range: $75,300-85,000 annually.
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: 283869.
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.