Sr. Regulatory Compliance Cord- IRB Position Available In Richmond, Georgia

Sr. Regulatory Compliance Cord IRB
Job ID
Location
Augusta University
FullPart TimeFullTime
RegularTemporaryRegular
About Us
Augusta University is Gia’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 , students choose Augusta for educational opportunities at the center of Gia’s cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Gia’s only public academic health center, w groundbreaking research is creating a healthier, more prosperous Gia, and worldclass clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values saugusta.eduaboutmission.php make Augusta University an institution like no other.
Augusta University’s distinct characteristics in education and research include realworld experiences andmunity engagement, as well as a culture of buildingmunity, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state.
The University System of Gia susg.eduhrorientationwee_to_the_board_of_regents_university_system_office isprised of our 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 ananization, and each USGmunity 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 …. and can be found online at .
Additionally, USG supports Freedom of Expression as stated in Board Policy . Freedom of Expression and Academic Freedom found online at Location
Augusta University
Our Health Sciences Campus th Street, Augusta, GA Our Summerville Campus Walton Way, Augusta, GA CollegeDepartment 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 meetspliance 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 andor human derived materials in regard to initiation, performance, andpletion to assurepliance 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 ensurepliance with federal, institutional regulations and AAHRPP accreditation guidelines and to identify areas of improvement for IRB administrators.
Training
Provide researchpliance 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.
ing
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 newrevised policies, SOPs, etc. related to research involving human subjects research
Audits
Conduct routine, rotational, and forcase audits of research studies involving human subjects and investigate possible research nonpliance
Prepare for and provide onsite 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 of cumulative experience inpliance and IRB related work. Experience with writing policies, SOPs, and guidance documents, knowledge of Human Subject Research federal regulations, and experience in developing educational presentationpublic 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 subjectsanizations is preferred.
Knowledge, Skills, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and otherputer softwaredatabases.
Thorough knowledge of human subject research including federal, state and institutional policies, procedures, regulations and guidance. SKILLS
Excellent interpersonal, written, and verbalmunication skills.
Detailoriented with stronganizational, planning, negotiation, team building and multitasking 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.
ShiftSalaryBenefits
Shift DaysMF (Work outside of normal business hours may be required).
Salary Range $,$, annually. Pay Band B
Salary to bemensurate 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 fulltime benefitseligible employees and some of our halftime (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 paid holidays.
Also, our fulltime employees who have been employed with us successfully for more than months can be considered for the Tuition Assistance Program. Consider ing 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.
Other Information
This position is also responsible for promoting a customerfriendly environment and providing superior service to our patients, students, faculty, and employees. “Augusta University is a patientand familycentered care institution, w employees partner every day with patients and families for success.”
Augusta University is a tobaccofree 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 weing applicants from underrepresented groups, including individuals with disabilities and veterans.