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IRB Consultant

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POST DATE 9/7/2016
END DATE 10/29/2016

Rush University Medical Center Chicago, IL

Company
Rush University Medical Center
Job Classification
Full Time
Company Ref #
2016-1964
AJE Ref #
576109713
Location
Chicago, IL
Experience
Entry Level (0 - 2 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

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JOB DESCRIPTION:

GENERAL SUMMARY: This position is responsible for providing support to the members of the Rush University Medical Center (RUMC) Institutional Review Board (IRB) and sub-committees, as well as the research community of Rush. The incumbent will review and process new project applications, analyze adverse event reports, amendments, and continuing review applications for the IRB and various sub-Committees. In addition, the incumbent will provide support to the IRBs. This position requires numerous skills which include coordination of many tasks, the ability to communicate to a variety of individuals, provide consultation, problem solving and conflict resolution, and teamwork. In addition, a solid understanding of the complex federal regulations governing human subject protections in research, along with RUMC policies and procedure are an essential component for this position. The incumbent will exemplify the Rush Mission, vision and values.



PRINCIPLE DUTIES AND RESPONSIBILITIES:

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Manage and facilitate all research submissions, internal and external to Rush.
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Pre-screen research submissions, ascertain the submissions contain the appropriate documentation before they go to the IRB for review.
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Facilitates and processes in a timely manner: Revisions, amendments and advertisements; and
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Correspondence pertaining to RUMC investigators and IRB chairpersons and members.
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Manage and facilitate work flow, including all required reviews prior to study release.
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Provides oversight and evaluation of status of study files (organization and completeness) in accordance with OHRP/FDA/NIH regulations and RUMC policies and procedures.
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Serve as a primary liaison between the RUMC investigator and IRB committee members.
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Resource for all RUMC investigators in relation to IRB submissions and related issues.
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Provides comprehensive consultation to the research community.
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Keeps current of trends in research and regulations and attends brown bag seminars and other educational opportunities to discuss these issues.
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Provide input in developing policies and procedures regarding the Human Subjects Division of the Office of Research Affairs. IV.
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Schedule and attend IRB meetings, will manage a minimum of one RUMC IRB meeting per
week and as required.
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Work with IRB Chairpersons to determine attendance (quorum) for IRB Committee meetings.
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Ascertain agenda items are appropriately delivered to IRB Committee members in a timely manner.
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Responsible for the adequacy and completeness and archiving IRB meeting minutes in accordance with Federal regulations.
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Keep IRB members apprised of educational opportunities at RUMC.
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Assist with the review and monitoring of reportable events, continuing reviews, amendments and all other regulatory requirements.
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Must be proficient in the Rush Research Portal and provide first level help desk support for the IRB module.
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Carries out special projects as assigned.
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Transcribes dictation as needed.



CRITICAL SKILLS/EXPERTISE:

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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 HIPAA are required.
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Excellent communication skills, demonstrated by an ability to comprehend verbal and written instructions and write in a legal document using excellent grammar, writing, and computer skills are an essential part of the position. In addition, a critical skill is the ability to work well and cohesively within a team and other divisions of the Office of Research Affairs.



MINIMUM EDUCATION & EXPERIENCE:

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BA/BS in relevant discipline required.
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Previous office experience working in an IRB office preferred.
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Detailed knowledge directly related to the application of Federal regulations related to the operations of the IRB, Human Subjects Protections and clinical research is highly desirable.
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Demonstrated management skills and/or experience is essential.
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Must be able to work independently with minimal supervision, have proven writing skills, which should be demonstrated in the form of written publications or a writing sample.
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Excellent oral communication and customer service skills are required on a daily basis.
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Certification as an IRB professional is highly desirable and if not certified, achievement should be a goal that is a constant focus.



Disclaimer: The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.