|JOB DESCRIPTION: Promotes the ethical conduct of research and ensures compliance with all institutional, federal, state, and local regulations and policies for the Institutional Review Board (IRB). Responsible for the effective operation and quality assurance of at least one major area of the IRB office's core functions and responsibilities, which may include: providing regulatory expertise, outreach and education, protocol review, oversight of Committee meetings and minutes, HIPAA privacy review, research study monitoring and compliance oversight, reporting to federal regulators and institutional officials, IRB member management, and IRB office staff development and management. Supervises the day-to-day operations of the IRB Analysts. Makes 'Not Human Subjects Determinations', 'Exemption Determinations', and acts as a designated reviewer for studies undergoing expedited review. Provides consultation to the community on application of federal and other applicable regulations to specific research situations. Proactively participates in the establishment of measures of success and target performance goals for area of responsibilities. Helps ensure that IRB policies, guidance, templates, and standard operating procedures relevant to the area of responsibility are up to date with changes in regulations and other applicable policies and laws. Identifies opportunities for process and quality improvement within the relevant area of responsibility and in the Human Research Protection Program (HRPP) overall.
Responsible for designing and delivering effective training and outreach presentations. Leads departmental subcommittees and working groups, as needed. In collaboration with the Director and Associate Director, assists with the optimal application of the federal, state, and local laws, guidance documents, Emory University institutional policies, and IRB policies and procedures while meeting the objectives of the Emory University research community. Serves in the Director's or Associate Director's absence, as appropriate. Assists with the preparation of materials for accreditation applications. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree in liberal arts, social sciences, health sciences or other related field and five years of IRB, research compliance or related experience, which includes experience in a lead or supervisory role, or an equivalent combination of education, training and experience. Significant IRB experience strongly preferred. CIP certification. Excellent written and oral communication skills.
Emory University is dedicated to providing equal opportunities to all individuals regardless of race, color, religion, ethnic or national origin, gender, age, disability, sexual orientation, gender identity, gender expression, veteran's status, or any other factor that is a prohibited consideration under applicable law.