IRB Coordinator

About the role

The primary responsibility for review and approval of social-behavioral human research applications from AU researchers and student researchers as well as investigators for IRB for oversight.

Responsibilities

• INTAKE ASSESSMENT AND INDEPENDENT DESIGNATED REVIEWER: Review exempt-category and social-behavioral expedited-category applications and render decisions for approval or modification. Review and approve modifications to approved projects, as permitted by regulations. Review reportable events and make appropriate decisions. Make Not Human Subjects Research determinations. Connect with the researcher/study researchers to acquire the needed information. Serve as liaison for the enterprise HRPP program to support the Community Engagement and Outreach Unit by partnering with various campus communities. Raise awareness to ensure submissions meet regulatory and human subjects' compliance requirements and offer tools to ensure human subjects' compliance adherence. Facilitate in-person and online forums and participate in class lectures to establish rapport and build communication. Manage Student Support Drop-In Hours for Summerville Campus. Host Monthly Lunch and Learns with Summerville Campus.
• GUIDANCE DOCUMENT MAINTENANCE: Work with units to develop and maintain application forms, processes, policies, and procedures to ensure compliance with the review of research protocols, as well as guidance and instruction for IRB and Investigators. Regularly audits and refines SOPs, guidance, and resources for researchers and reviewers.
• IRB COMMITTEE B, SOCIAL, AND BEHAVIORAL COORDINATION: Conduct a pre-review analysis of IRB submissions to ensure applications are adequately prepared and to identify any missing information that would preclude the ability to conduct an adequate review. Manage IRB Social and Behavioral IRB operations, including meeting management and pre- and post-meeting activities. Process response approvals for IRB B research applications that received modifications requiring a determination. Maintain appropriate documentation and reporting of review, study status, and panel activities. Create federally mandated institutional records in the form of meeting minutes that summarize the discussions and deliberations of the IRB in conformance with regulatory agency standards. Consult with the IRB Training Coordinator/IRB Education and Quality Coordinator to develop educational resources.
• HUMAN RESEARCH PROTECTIONS LIAISON: Advise investigators regarding federal and university policies regarding human research. In conjunction with the IRB Training Coordinator, provide training to the Summerville campus on IRB processes and federal regulations. Serve as a resource for investigators, research personnel, students, student researchers, and staff.
• OTHER: Perform other duties as assigned.

Required Qualifications

• Bachelor's degree from an accredited college or university in a related field and a minimum of three years of experience and knowledge directly related to IRB operations and human research protections including ethics, clinical trial performance, or in an academic IRB.

Preferred Qualifications

• Certification as an IRB professional is highly desirable OR the ability to obtain within 2 years. Certification as a Certified Clinical Research Coordinator or Certified Clinical Research Associate highly desirable.

Knowledge, Skills, & Abilities

• KNOWLEDGE: Proficient in Microsoft Office and other computer software/databases.
• SKILLS: Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong prioritization and organizational skills. Demonstrated skill in running effective meetings.
• ABILITIES: Ability to maintain confidentiality. Ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45CFR46, 21CFR50/56, HIPPA Good Clinical Practice, the Declaration of Helsinki, the Belmont Report, and the AU IRB Policies and Procedures. Ability to exercise creativity in solving problems effectively while employing good judgment. Seeks opportunities to enhance professional advancement. Demonstrated ability to work independently with minimal supervision. Ability to function in a team environment.