Sr. Regulatory Compliance Cord- IRB
Job ID: 279613
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
Audit and provide ongoing monitoring of all processes of research study involving human subjects and/or human derived materials in regard to initiation, performance, and completion to assure compliance with the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), the Veterans Health Administration (VHA) regulations and best practice guidance as well as institutional policies and procedures and state law. This individual will also serve as backup to the Regulatory Compliance Manager.
Responsibilities
Responsibilities to include but not limited to:
Conduct quality assessments
Conduct quality assessments of internal IRB submissions prior to release of IRB approvals to ensure compliance with federal, institutional regulations and AAHRPP accreditation guidelines and to identify areas of improvement for IRB administrators.
Training
Provide research compliance training and guidance to researchers and IRB staff as needed for study startup; as part of the audit corrective actions; and other times as deemed necessary.
Reporting
Assist in preparing reports for the Regulatory Compliance Manager, the IRB Committee, and IRB Leadership as needed.
Policies
Assist with review, revisions, and benchmarking of new/revised policies, SOPs, etc. related to research involving human subjects research
Audits
Conduct routine, rotational, and for-case audits of research studies involving human subjects and investigate possible research non-compliance
Prepare for and provide on-site assistance with external audits and institutional site visits
Other Duties
Perform all other related duties as assigned.
Required Qualifications
Bachelor's degree preferably in a scientific field or healthcare field. Three years cumulative experience in compliance and IRB related work. 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
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 organizations is preferred.
Knowledge, Skills, & Abilities
Proficient in Microsoft Office and other computer software/databases.
Thorough knowledge of human subject research including federal, state and institutional policies, procedures, regulations and guidance.
SKILLS
Excellent interpersonal, written, and verbal communication skills.
Detail-oriented with strong organizational, planning, negotiation, team building and multi-tasking skills.
ABILITIES
Ability to maintain confidentiality.
Ability to function both as an independent and as a team member.
Ability to establish rapport and trust with research team members.
Shift/Salary/Benefits
Shift: Days/M-F (Work outside of normal business hours may be required).
Pay Band: B11
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 candidates are required to successfully pass a Background Check review prior to starting with Augusta University.
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 the course of their employment and beyond.
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=279613&PostingSeq=1
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