| Compliance Specialist -- Kansas City, MO |
Author: Sheila Anderman
Date: 08-24-10 18:41
The University of Missouri-Kansas City (UMKC) is an urban institution with over 14,000 students, more than 500 fulltime faculty members, and twelve academic units spanning the sciences, engineering, humanities, and arts, including a major health science center with schools of dentistry, medicine, nursing, and pharmacy. External research funding exceeds $50 million per year, and partnerships with Truman Medical Center, Children¿s Mercy Hospital, Stowers Institute for Medical Research, Kansas City Area Life Sciences Institute, Midwest Research Institute and local health care institutions extend the reach of UMKC to the community of Kansas City and beyond.
This position is responsible for the day-to-day operations and support, along with another IRB Compliance Specialist and the Compliance Manager, of two Institutional Review Board for the Protection of Human Subjects (IRB) committees to facilitate protocol submission, review, and approval processes and ensure institutional compliance with regulatory standards for federal and state laws, regulations, institutional policies and guidelines governing human research protection.
Duties of the IRB Compliance Specialist 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 to complete an application for respective committee review.
- 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 the director.
- Reviews 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.
- Monitor continuing (semi-annual or annual) review process; support reviewer for completion of the review.
- 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 Manager requests as needed.
- Ability to manage multiple deadlines, prioritize competing goals, and work in a deadline intensive environment.
Minimum Qualifications
A Bachelors degree or an equivalent combination of education and experience is required and two or more years of experience in IRB compliance and/or administrative aspects of clinical research, or a closely related area.
Preferred Qualifications
o Bachelor's or Master's degree in a science or social science related field, with 1-2 years experience with Institutional Review Board for the Protection of Human Subjects (IRB) administration. Two plus years of direct IRB experience would be considered a plus.
o Certification as an IRB Manager or Senior IRB Specialist.
o Ability to maintain confidentiality with tact and discretion and be able to interpret and apply ethical principles to his/her daily work.
o CITI Training.
o Ability to manage multiple deadlines, prioritize competing goals, and work in a deadline intensive environment with a high level of accuracy and attention to detail.
o Ability to work both independently and in a close team environment and to coordinate a volume and variety of programs and meetings.
o Computer literate, with working knowledge of Microsoft Office and similar software
o Excellent, demonstrable communication skills, both written and verbal
o Ability to work with all levels of employees in a respectful and supportive manner.
o Working knowledge of research and medical terminology
Full Time/Part Time
Full Time
Go to http://www.umkc.edu/hr/career-opportunities/administrative-job-posting-onlineapp-intro.asp
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