IRB Regulatory Coordinator

The Institutional Review Board (IRB) Coordinator plays a critical role in providing accurate guidance and regulatory support to Cone Health researchers (faculty, staff, residents, fellows and students) engaged in human subjects research. The IRB Coordinator will serve as the primary regulatory support resource for all researchers and staff at Cone Health. As such, the IRB Coordinator must have an extensive understanding of human subjects research regulations and will assist Cone Health researchers in adhering to IRB requirements, federal and state regulations, state law, institutional policies, and the ethical principles that apply to human subjects research. The IRB Coordinator conducts reviews of human subject research applications to determine the appropriate level of review and to assure compliance with applicable requirements, manages the online human subject protection training program, reviews materials submitted to the IRB in accordance with applicable regulations, coordinates IRB matters with the IRB Chair, Co-Chairs, Associate Director of Clinical Research, and others (as appropriate), and assists Cone Health personnel with human subject protection issues and with IRB review. The IRB Coordinator also manages and performs data recording/record keeping operations and assists with the Conflict of Interest Disclosure process for researchers, as required by institutional policies.

Specific job responsibilities/functions in support of the Cone Health IRB include:

• Support and assist researchers in using IRBNet, the electronic IRB application review software
• Assist in the development/maintenance of IRB application forms, templates, the IRB internal SharePoint site and other IRB resources
• Conducts preliminary review of human subject research applications, modifications, and continuations to assure completeness and inclusion of all required documents
• Reviews human subject research applications to determine the appropriate level of IRB review
• Coordinates notifications for continuation review or closure of active protocols
• Coordinates IRB meetings in conjunction with the IRB Chair, including preparation and distribution of IRB meeting materials
• Records, prepares, and distributes minutes of all IRB meetings
• Monitors action items from IRB meetings that require follow up to assure that necessary actions are taken
• Helps maintain accurate records and institutional files, including application/protocol materials, correspondence, modifications and unanticipated problem/adverse event reports, in accordance with all applicable regulations, institutional policies, and best practices
• Helps conduct post approval monitoring and for-cause audits of research protocols with the Associate Director of Clinical Research, as needed
• Provides administrative support to the IRB Chair

Specific job responsibilities/functions in support of Cone Health researchers include:

• Tracks education compliance for researchers, IRB members, and others engaged in human subjects research on behalf of or at Cone Health and its affiliate sites
• Provides technical assistance to researchers engaged in research involving human subjects
• Works with researchers and research staffs to coordinate continuing review required to assure compliance with
• federal, state, and university requirements
• Assists with the documentation of Conflict of Interest (COI) Disclosures for Cone Health researchers
• Maintains Cone Health’s Collaborative Institutional Training Initiative (CITI) Training account and provides guidance to researchers and research staff needing assistance with CITI training
• Maintains a thorough working knowledge of and ability to apply federal regulations and other relevant requirements pertaining to research involving human subjects, most particularly Title 45 Code of Federal Regulations Part 46 (45 CFR 46 "Basic HHS Policy for the Protection of Human Subjects") as implemented by the United States Department of Health and Human Services (HHS).

• Minimum of two years of directly related experience
• Prior IRB experience required
• Expertise in regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA
• Strong knowledge of protocol processes and approval mechanisms included in ongoing human subject research oversight.
• Strong communication (written and oral), interpersonal, and customer service skills needed to work closely and effectively with researchers, committee members and administrative personnel.
• Detail-oriented with the ability to multi-task and prioritize workload
• Certified IRB Professional (CIP) Certification preferred