Analyst for the Institutional Review Board

Job Title - Analyst for the Institutional Review BoardUnder delegated authority from the Chancellor of East Carolina University, the Chief Innovation and Engagement Officer and Interim Chief Research Officer is accountable to the Federal government and other regulatory agencies for protection of humans who are the subject of any research by investigators within East Carolina University. The University and Medical Center Institutional Review Board (UMCIRB) is the entity which oversees all human subject research, under delegated authority from the Chief Innovation and Engagement Officer and Interim Chief Research Officer.The UMCIRB reviews human research plans from all across ECU’s campus, the ECU Health system and has affiliations with other entities to conduct their reviews. Such research includes clinical or patient-related research, including clinical trials. It also includes surveys and other types of research using human subjects, such as research conducted with children by the College of Education; psychological research involving adults and children; and all other types of human research throughout the university.The primary purpose of the Analyst for the Institutional Review Board (IRB) is to support the overall administration of the human research review and approval process, providing high-level support and guidance to investigators and other stakeholders, and streamlining IRB processes. Through these activities, the Analyst for the Institutional Review Board helps ensure that the University’s human research activities are in compliance with institutional SOPs and international, federal, state, and local rules and regulations, and the ethical principles regarding the involvement of humans in research to protect their safety, rights, and welfare.The Analyst for the Institutional Review Board will be responsible for screening and processing human research applications in accordance with human research related regulations, rules, and policies. This position will aid all customers and will analyze and interpret complex regulations, rules, and guidance related to human research in order to serve as a process expert. The Analyst for the Institutional Review Board will effectively communicate, both written and verbally, and serve as a dependable resource for a wide variety of customers.This position will also understand and support the technology required for conducting daily business. This position requires interpretation of federal regulations and guidance and evaluating human research application received by the UMCIRB. The position will work closely with other staff, investigators with varying levels of experience, and administrative leaders to support the human research enterprise. This position performs the following duties:UMCIRB Pre-review Process: 40%• Conduct preliminary screening and evaluation of human research studies submitted for UMCIRB review to assess adherence to requirements for IRB approval.• Provide effective feedback to investigators based on identified issues prior to review by the UMCIRB and provides mediation to identify and resolve issues. • Employ critical thinking to solve moderately complex problems and effectively use available tools in problem solving and analysis. • Accurately conveys UMCIRB determinations to investigators via the electronic IRB submission system. • Identifies, plans and implements strategies to enhance the research submission and review process. • Consistently operates according to UMCIRB policies and procedures for the protection of human participants in research.Office and Administrative Operations: 20%• Work independently and with minimal supervision to accomplish responsibilities. • Manage and shepherd IRB Reliance Agreements and Individual Investigator Agreements to ensure proper execution. • Participate in policy and procedure development and implementation and develop tools and resources for the UMCIRB website to enhance investigators’ use based on routine investigator questions and experiences. • Convey technical information to clients and promote understanding of relevant issues.• Interact as a productive team member on a project team and/or manage project tasks. • Assist in the preparation for and conduct of audits by both internal and external bodies. • Manage IRB records for appropriate data retention and destruction. • Check main UMCIRB email account, issues log and registrations on behalf of the office as designated. • Informally tracks and identify groups or individuals experiencing ongoing difficulties with the IRB process and work with colleagues to create a strategy for resolution.• Participate in post IRB-approval monitoring including but not limited to: routine and for-cause monitoring of human research, reporting findings from monitoring to appropriate parties, development of educational and training programs and development and dissemination of materials such as study tools, templates, and guidance for use by investigators and key study personnel. • Work on special projects as assigned by Director. Training and Consultation: 20%• Develop training materials for investigators based on institutional policies, state laws, and federal regulations and guidance.• Conduct education sessions and training, either formally or informally, for IRB customers based on new policy information or based on noted needs of the investigators utilizing IRB services. • Provide education and training for UMCIRB members for discussion at UMCIRB meetings and UMCIRB member retreats. • Provide guidance and interpretation to investigators that need assistance by educating and explaining why requests are being made. UMCIRB Meeting Coordination and Support: 15%• Research and gather information on controverted issues that may arise during UMCIRB meetings in order to provide accurate and timely guidance to the IRB.• Participate in creation, verification and proper dissemination of agenda items for IRB meetings. • Secure meeting location and necessary equipment (or other coordinating activities) for UMCIRB meetings and ensure quorum is secured as required by federal policy. • Accurately record UMCIRB meeting minutes and effectively communicate meeting information to investigators. • Construct and process approval letters from the UMCIRB meeting and other correspondence as necessary. Other: 5%• Other Duties as assigned.Minimum Education/Experience• Bachelor’s degree and one year of experience related to the area of assignment; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. Preferred Experience, Skills, Training/Education• Experience with electronic data management systems. • Experience with regulatory documents and interpretation of said documents and summarizing information to convey to relevant parties. • Experience in the development of standard operating practices and educational workshops & training.• Experience working in a university and/or research setting. • Certification as an IRBProfessional (CIP); Clinical ResearchProfessional (CCRP); or Clinical Research Associate (CRA) or eligibility to apply for certification. • Knowledge of biomedical research, social, behavioral or education research, data security and confidentiality, multi-site and collaborative research. • General knowledge of Good Clinical Practice (GCP), ICH, FDA, OHRP, federal regulations related to human subjects’ research as well as the ethical principles in the Belmont Report.• Strong verbal and written communication skills and good customer service skills. Apply tot his job