| Compliance Officer -- Kansas City, MO |
Author: Jon Merz
Date: 06-09-11 16:17
Hiring Department
Research Services - Research Compliance Office
Department Overview: The UMKC Office of Research Services is comprised of four major subunits, including the Office of Research Compliance. Research Compliance under the new leadership of Chris Winders, Director, is responsible for administering and managing five compliance committees, including Adult Health IRB, Social Sciences IRB, IACUC, Institutional Biosafety, and Radiation Safety.
Job Description
This Compliance Officer position is responsible for providing significant support and expertise, along with another IRB Compliance Officer, to two (2) Institutional Review Boards for the Protection of Human Subjects (IRB) committees for protocol submission, decision support, and compliance with regulatory standards for Federal laws, National standards, and Institutional Policy, by facilitating and administratively supporting these committees. Activities include participating in the protocol submission and review process; preparation of required federal and institutional reports; designing instructional materials to satisfy federal educational requirements of faculty, staff, and students; serving as one of the university's back-up points of contact with the appropriate state and federal regulatory bodies; formulating, interpreting, implementing, and ensuring compliance with policies and regulations.
Duties of the IRB Compliance Officer include, but are not limited to:
* Knowledge currency of federal regulations involving IRB compliance.
* Review new applications for category of review, potential problems, and compliance with committee standards.
* Communicate to Investigators items that require clarification or documents required for submission in order complete an application for respective committee review.
* Act as a central contact for faculty and staff to assist with proposal preparations to ensure submissions comply with board/committee and university policies & procedures, and that submissions meet deadlines and requirements.
* Serve as liaison between the research faculty, board/committee, management, and other staff.
* Assign reviewer, monitor/support reviewer for completion of review.
* Resolve problem applications with reviewer and investigator (this requires in-depth knowledge of the federal regulations and university policy); refer unresolved problems to compliance management.
* Review emergency requests, amendments and revisions for completeness and compliance with committee standards prior to convened IRB review.
* Coordinate with IRB team to set the meeting agenda.
* Attend and assist at meetings, including recording substantive changes to consent or application.
* Initiate approval process for projects including forwarding appropriate documentation requiring change, notifying investigators of additional Board requirements, review final consents and responses from investigators, generate approval letter and complete database entry.
* Review amendments. Forward to Member(s) or Chair as appropriate for signature.
* Review adverse events and forward to Chair or Vice Chair.
* Provide guidance to board/committee members during deliberations on policy and regulatory requirements. Assist in reviewing board/committee related policies and recommend revisions and enhancements as necessary to maintain uniformity among human research review committees.
* Monitor continuing (semi-annual or annual) review process; support reviewer for completion of the review.
* Review and approve exemption requests.
* Provide computer skills (user not technical) and support for the implementation of an electronic submission process.
* Maintain database and create reports from the database.
* Respond to Compliance Director’s Requests as needed.
* Ability to manage multiple deadlines, prioritize competing goals, and work in a deadline intensive environment.
* Ability to maintain confidentiality with tact and discretion and be able to interpret and apply ethical principles to his/her daily work.
* Ability to work both independently and in a close team environment and to coordinate a volume and variety of programs and meetings.
Minimum Qualifications
* A Bachelors degree or an equivalent combination of education and experience from which comparable knowledge and abilities can be acquired is necessary.
* Computer literate, with working knowledge of Microsoft Office and similar software
* Excellent, demonstrable communication skills, both written and verbal
* Ability to work with all levels of employees in a respectful and supportive manner.
* Working knowledge of research and medical terminology
* Three or more years of experience in IRB compliance and/or administrative aspects of clinical research, or a closely related area.
Preferred Qualifications
* Bachelor's or Master's degree in a science or social science related field, with 4 years experience with Institutional Review Board for the Protection of Human Subjects (IRB) administration.
* CIP Certification or IRB Manager Certification.
* CITI Training.
Full Time Position
Application Deadline
Monday, June 29, 2011
Application Instructions
Apply online: www.umkc.edu/jobs (Position #00032831).
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| Topics |
Author |
Date |
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Compliance Officer -- Kansas City, MO |
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Jon Merz |
06-09-11 16:17 |
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