The NC State Institutional Research Board (IRB) office provides ethical and regulatory oversight for all NC State research involving human subjects as participants. NC State has one IRB committee led by the IRB Director and the IRB Chair that focuses on both Biomedical and Social, Behavioral, and Educational Research (SBER). The IRB office is made up of three or four professional staff members, which at any one time may include temporary employees, graduate students, entry level professionals, and mid-level professionals. The Director of the IRB will directly supervise all IRB staff and facilitate the operation of the IRB Full Board. This position is responsible for managing daily operations, processes, systems, policies, strategic plans, vision, education and training, and problem-solving related to the ethical and regulatory aspects of research with human subjects. Essential Job Duties: - Provide leadership and support of human subject research protections in a diverse academic environment - Develop and maintain IRB policies and procedures that are compliant with federal regulations and current best practices. - Hire, train, supervise, and evaluate personnel within the IRB office. - Review and approve any research that meets the federal criteria for Exemption or Expedited review including initial reviews, amendments, continuing reviews, and just-in-time reviews. - Receive and reconcile reported issues of unanticipated problems, adverse events, and complaints - Recruit, select, and train all IRB Full Board members, including the IRB Chair. - Identify, manage, and resolve instances of non-compliance that must be reviewed by the Full Board in accordance with federal regulations. - Plan and deliver outreach and education activities for the university research community - Serve as primary voting member and facilitate reviews and discussion IRB Full Board meetings. - Develop and enact a comprehensive assessment plan for the IRB Full Board and Office. - Determine when an Institutional Authorization Agreements (IAA) are and serve as signatory/designee for said agreements. - Serve as liaison between NC State and research related federal agencies and between the IRB Office and University personnel, helping researchers understand and fulfill federal requirements. - Serve on University committees as an IRB representative for research related University level. committees and consult with related units at the University to facilitate compliant research at NCSU. - Serve as IRB Administrator, as defined by regulation. - Should the need arise, this position is expected to perform job functions of all IRB staff.
Minimum Qualifications: * A Master's degree is required. * A minimum of 5 years of direct experience working with an Institutional Review Board and/or in an IRB office is required. * Thorough understanding of the legal and regulatory frameworks for the transfer and use of human subject data. * Excellent oral and written communication skills. * Proficiency in administrative skills and time management. * Ability to balance ethical considerations and regulatory requirements. * Ability to navigate complex ethical situations. * Experience in applying regulations to practical situations. * Ability to create and implement effective policies and procedures. * Experience in direct supervision of subordinates. * Critical thinking and attention to detail.
Position Number: 00007627
Posting Date: 07/13/2018
American Recovery & Reinvestment Act Funded: No