Director, Office Human Research Protection
Job ID: 252010
Location: Augusta University
Full/Part Time: Full-Time
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 9,000 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.
Augusta University –
Our Health Sciences Campus:
1120 15th Street, Augusta, GA 30912
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.
The Director for Human Research Protections, is a vital member of the senior leadership team in Augusta University's Office for Research Administration (OR). The Director is responsible for overseeing and ensuring the efficient and effective operations of the Human Research Protection Program. The Director keeps the SVP for Research informed of developments, particularly at the federal level, within and related to the Director's areas of responsibility, providing recommendations and seeking counsel from the VPR to ensure the continuous delivery of outstanding service to AU's research community while maintaining and enhancing compliance with ethical and regulatory requirements. Specific to the AU's Human Research Protection Program (HRPP), the Director serves as the Human Protections Administrator under the University's Federal wide Assurance, as well as according to the Association for the Accreditation of Human Research Protection Programs accreditation, and is hence responsible for the appropriate functioning of the HRPP. The Director is actively engaged in building and maintaining relationships with internal and external collaborators. Through service on various AU committees the Director influences policy and process, building consensus and consistency in coordination with other units and schools.
The duties include, but are not limited to:
Management of IRB Office: Oversee the direction and supervision of the IRB Office personnel to ensure that the IRB operations, education, and compliance missions are evaluated and achieved: Manage the day to day IRB Office functions and IRB Office; Manage IRB Office budget to include the IRB Revenue account; Review staffing levels and activity and conduct periodic performance evaluations; Promote research and scholarship within the units of the IRB Office; Oversee functions and services of IRB Operations Manager, IRB Regulatory Compliance Manager, and their staff.
Human Protections Administrator: Provide leadership and guidance to the Augusta University Human Research Protection Program (HRPP) to include the IRB Office, ensuring it is structured and resourced to provide efficient and effective support to the research internal and external communities in compliance with regulatory and legal obligations. Responsible for the appropriate functioning of the University's Human Research Protection Program (HRPP). Serve as an adviser and resource in the field of human subjects' protection, regulatory compliance and quality improvement associated with protocols conducted within the AU Health System including all campuses, AU Health, Inc., Physicians Practice Group and the Charlie Norwood Veterans Affairs Medical Center and to ensure consistency across all research policies and functions and ensuring cross functional data harmonization. Serve as the Human Protections Administrator for the University's Federalwide Assurance, assuring compliance with the federal regulations for the protection of human subjects in research; Serve as the Human Protections Administrator for the Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation, indicating that the University follows rigorous standards for ethics, quality, and human research protection. Lead all AAHRPP accreditation efforts to include maintenance of reaccreditation and annual reports. Collaborate with the SVP for Research, other AVPs, and unit directors in Augusta University regarding the functions and operations of the HRPP. The Sr. Director influences policy and process, building consensus and consistency in coordination with other units and schools. Act as the organizational resource for all human compliance issues and collaborating with researchers on all compliance issues including IRB requirements or human subjects protection issues including dissemination of information to members, investigators and staff on regulatory. Collaborate with colleges and units across the University, addressing areas of concern related to conducting human research. Design and plan special projects designed to enhance office procedures, HRPP performance, overall human subjects protections and general research compliance; Advise the Institutional Official and IRB Chairpersons on matters related to research non-compliance while maintaining a high level of awareness regarding the ethical conduct of research and safeguarding the rights and welfare of human research subjects. Understand and keep abreast of federal and state regulatory environments and University policies relating to human research to ensure the SVP for Research and senior leadership are apprised of research regulatory issues and significant new developments. Acquire and apply DHHS, FDA, and VHA federal regulations for the protection of human subjects to specific research situations which requires an extensive knowledge of both DHHS (45 CFR 46), FDA (21 CFR 50 and 56), and VHA (38 part) human subjects regulations and appreciation of related regulatory, ethical and compliance principles; Familiarity with other regulations and guidance (e.g. CMS, HIPPA) that may be applicable in human research subjects studies.
HRPP Community Engagement and Outreach: Provide oversight and direct administration of the HRPP Community Engagement and Outreach Administrator to include activities and initiatives designed to engage the CSRA and Georgia citizens who the AU HRPP serves.
Policies, Guidelines, and Applications: Responsible for the development of policies, guidelines, and applications for the protection of human participants, in conjunction with the Sr. Vice President for Research. Provide oversight on new policies, policy interpretation, and revisions when needed.
Building and Maintaining Relationships: Actively engage in building and maintaining relationships with the clinical affiliates to which the University provide human research support: Augusta University Health System, Physicians Practice Group, Charlie Norwood VA Medical Center, Medical College of Georgia at Augusta University Satellite Campuses.
Electronic Systems: Ensure the IRBs have robust electronic systems to support the University's HRPP: Identify and assess setting-appropriate electronic IRB management systems, successfully implementing selected systems and submission processes; Ensure that valid, informative and appropriate documents and data reports are generated.
Member of Various Committees: Influences policy and process through service on various University committees, such as Conflict of Interest, IRB Leadership, Translational Research Facilitation, and the Augusta University Health Data Governance Council necessary to ensure that human research protections are built in as necessary (example: electronic medical record, research data warehouses, etc.)
Other: Provide guidance on human research-related conflicts of interest, procedures and emergent matters. Develop efficient IRB submissions and response processes and suggest changes to the IRB Chairs and Sr. Vice President for Research. Present seminars and workshops on the protection of human participants in research to faculty, staff, students, and the community. Engage at the national level on matters relating to areas of responsibility through professional meetings and national forums. Perform other duties as assigned.
Master's degree from an accredited college or university, with a minimum of 5 years of directly related experience. Certified IRB Professional (CIP) or Certified IRB Manager (CIM). OR Bachelor's degree from an accredited college or university in a scientific or management field, with the Certified IRB Professional (CIP) or Certified IRB Manager (CIM) and a minimum of 8 years of direct experience in a research or regulatory environment, particularly in human research protections. A demonstrated track record of effective leadership in higher education, government, or commercial.
Advanced degree (e.g., MA, MS, JD, PhD).
Knowledge, Skills, & Abilities
Must have thorough knowledge of federal regulations, state laws and accreditation standards related to human subjects protections (investigator, sponsor, sponsor/investigator, IRB, privacy board, etc.) as well as the ability to implement those into appropriate training and auditing programs; Effective leadership and management skills, with the ability to develop staff while delegating authority and responsibility; Strong interpersonal, communication, analytical, and organizational skills; Ability to lead a team of diverse units; Ability to deal effectively with difficult situations; Ability to work effectively with a wide range of internal and external constituencies, including faculty members, staff across the University, students, and oversight agencies; Ability to maintain a working environment characterized by effective teamwork and collaboration with peers; Commitment to high ethical standards. The ability to manage confidential information; A deep appreciation of and respect for academic values and culture and an understanding of the critical role that the position; Serves in sustaining and broadening a research university's intellectual rigor; Ability to excel in a team environment.
Shift - Monday - Friday (Work outside of normal business hours may be required)
Pay Grade - 25
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.
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.
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
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