Research IRB Coordinator

Carle Health•Urbana, IL

2d•$22 - $37

About The Position

Work closely with Carle Institutional Review Board (IRB) Chair, IRB/Human Subject Protection (HSP) Manager, and other HSP staff in implementing an efficient, effective and compliant human subject protections program. Manage study intake and review process, assist in identifying and resolving issues, thoroughly document IRB decisions, and communicate IRB decisions to investigators. Additional responsibilities include internal form maintenance and review, provide educational activities (for research coordinators and IRB members), and represent the IRB to investigators.

Requirements

Certifications: Certified IRB Professional (CIP) within 3 years - Public Responsibility in Medicine and Research (PRIM&R)Public Responsibility in Medicine and Research (PRIM&R)
Education: Bachelor's Degree: Related Field (Required)
Work Experience: IRB

Responsibilities

Reviews and evaluates research submissions involving human subjects in a timely and professional manner.
Reviews submissions to the IRB for accuracy, completeness, clarity, and information integrity.
Determines regulatory oversight, level of IRB review needed, and compliance with federal, state, and local regulations, policies and guidelines.
Works with principal investigators (PI) and study staff to resolve issues related to IRB submissions.
Accurately applies regulatory and institutional knowledge to a variety of complex fact patterns and communicate directly with investigators and/or study coordinators to resolve problems.
Reviews and approves Prep to Research and Closure submissions, communicating revision requests to investigators and resolving issues, and documenting determination decisions.
Manages unanticipated problem reports, deviation reports, and subject complaints, providing pre-review and resolving issues or forwarding issues as appropriate to the Senior IRB Coordinator or IRB/HSP Manager.
All communications, IRB review, and decisions must be thoroughly documented.
Creates, maintains, and enhances working relationships with internal and external customers.
Assists in the research, drafting, testing, and finalization of IRB policies and forms.
Drafts office procedures in cooperation with other HSP staff.
Assists in the preparation of educational materials for staff, investigators, and IRB trainings.
Audits IRB study files to ensure that the content is accurate and complete and consistent with the database for quality assurance purposes.
Maintains IRB records according to Federal regulations/guidelines.
Serves as an alternate IRB committee member.
Responsible for identifying and developing new website content.
Participates in professional activities, attends national meetings, and regulatory seminars.
Performs other assignments as directed.