SR. IRB Consultant
Dept: Research and Clinical Trials Administration Office This professional and highly visible position is responsible for providing support to the RUsh University Medical Center (RUMC) Institutional Review Boards (IRBs).
Review and facilitate the flow of new research submissions and renewals, revisions, amendments and advertisements through the review process to the IRB. Extract and summerize pertinent and complex clinical information in written/verbal reports, including minutes.
Collaborate with Principle Investigator(s)/Coordinators.
This position requires coordination, facilitation, consultation and conflict resolution skills and an understanding of the complex federal regulations governing human subject research to assist investigators in the submission of their research proposals.
Additional Information Position Type: Full-Time Education/Special Skills Required: Critical Skills/Expertise: Strong knowledge of the Federal Code of Regulations pertaining to Human Subject Protections, including 45CFR46, 21CFR50, and 56, Good Clinical Practice, the Declaration of Helsinki, the Belmont Report and HIPPAA.
Ability to comprehend verbal and written instructions.
Excellent communication skills required.
Excellent grammer and writing, and word processing skills.
Minimum Education and Experience: BA/BS in relevant discipline preferred, will consider an individual with some college experience who meets other criteria.
Three-five years of office experience working with an IRB office or a study coordinator preferred.
Detailed knowledge directly related to the application of Federal regulations related to the operations of the IRB, Human Subjects Protections and clinical research.
Demonstrated management skills and/or experience.
Must be able to work independantly with minimal supervision, have proven writing skills, which should be demonstrated in the form of written publications, excellent oral communication and customer service skills.
Certification as an IRB professionla is highly desirable and required within 18 months of hiring if not certified.
Shift: 1st Shift
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