Research IRB Coordinator

Overview: 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. 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. Qualifications: 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 Carle Health Company Overview:

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Discover the job, the career, the purpose you were meant for. At Carle Health, we're committed to fostering a workplace where every team member feels valued, respected and empowered, where passion and purpose come together to positively impact the lives of our patients and our communities. Find it all at Carle Health.

Our nearly 17,000 team members and providers work together to support patient care across central and southeastern Illinois.  We’ve grown to include eight, award-winning hospitals and a multispecialty provider group with more than 1,500 doctors and advanced practice providers. We’re developing the next generation of providers and healthcare professionals through Carle Illinois College of Medicine, the world’s first engineering-based medical school, and Methodist College. Carle BroMenn Medical Center, Carle Foundation Hospital, Carle Health Methodist Hospital, Carle Health Proctor Hospital, Carle Health Pekin Hospital, and Carle Hoopeston Regional Health Center hold Magnet® designations, the nation’s highest honor for nursing care. We offer opportunities in several communities throughout central Illinois with potential for growth and life-long careers at Carle Health.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. Carle Health participates in E-Verify and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization. | For more information: [email protected].

Salary Range: The compensation range for this position is $21.87per hour - $36.52per hour. This represents a good faith minimum and maximum range for the role at the time of posting by Carle Health. The actual compensation offered a candidate will be dependent on a variety of factors including, but not limited to, the candidate’s experience, qualifications, location, training, licenses, shifts worked and compensation model. Carle Health offers a comprehensive benefits package for team members and providers. To learn more visit careers.carlehealth.org/benefits. Apply To This Job