This role is remote with on site training and meeting when scheduled.

The Georgia Institute of Technology Office of Research Integrity Assurance (ORIA), in collaboration with federally mandated faculty oversight committees and boards, promotes the ethical conduct of research and ensures compliance with institute policy, state law, and federal regulatory requirements relating to research involving human subjects, vertebrate animal subjects, recombinant deoxyribonucleic acid (rDNA), synthetic nucleic acids, and export controlled research. In compliance with those policies, laws, and federal regulations, this office administers the affairs of the two Institutional Review Boards, the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee (IBC). This office also provides export control review and guidance for research activities subject to U.S. export control laws promulgated by the U.S. Department of State, the U.S. Department of Commerce, and the U.S. Treasury Department. ORIA maintains the institute’s Assurances and/or registrations with the Office for Human Research Protections, the Office of Laboratory Animal Welfare, and the Office for Research Integrity, all federal agencies within the federal Department of Health & Human Services. The Department of Defense has additional Assurance requirements. (Assurances are essentially “licenses” that permit the institution to receive federal funding for certain research activities).

The Research Associate I position shall (a) review protocols involving human research subjects and prepare a detailed written assessment with specific guidance necessary for eventual Institutional Review Board (IRB) approval; (b) instruct and guide academic and research faculty, staff and students through the approval process, including specific additional federal agency and international site requirements, providing direction as necessary; (c) Review funding contract or grant language to ensure that proposed research activities are consistent with contractual and federal requirements; (d) Consultation with Institutional Review Board(s) to facilitate final approval; (e) Collaborate with numerous Georgia Tech offices e.g., Legal Affairs, Office of the General Counsel, Risk Management, Environmental Health and Safety, and outside consultants and experts; (f) Design and deliver training programs and workshops to faculty, staff, and students; (g) Assist in the investigation, evaluation, and reporting of non-compliance matters as appropriate.

Educational Qualification - Bachelor's degree.

Education: Master's Degree

Work Experience: Six years with a BS or 4 years with a Masters Degree

Certifications: Certified IRB Professional (CIP) or ability to obtain CIP within one year of hire date

The ideal candidate shall posess

• In-depth understanding and mastery of Title 45 Code of Federal Regulations Part 46 including Subparts A, B, C, and D (the “Common Rule”); Title 21 CFR Part 50, 56, 312 and 812 (the Food & Drug Regulations); the Health Insurance Portability and Accountability Act (HIPAA); and 32 CFR Part 219 (the Department of Defense).
• Ability to work with demanding professionals in a high pressure environment.
• The ability to present complex material to a sophisticated academic audience.

For any further information please contact Kelly Winn at kw164@gatech.edu.

Georgia Tech provides equal opportunity to all faculty, staff, students, and all other members of the Georgia Tech community, including applicants for admission and/or employment, contractors, volunteers, and participants in institutional programs, activities, or services. Georgia Tech complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities. Georgia Tech prohibits discrimination, including discriminatory harassment, on the basis of race, ethnicity, ancestry, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetics, or veteran status in its programs, activities, employment, and admissions. This prohibition applies to faculty, staff, students, and all other members of the Georgia Tech community, including affiliates, invitees, and guests.