| Research Compliance Specialist Senior –- Flint, MI |
Author: Jon Merz
Date: 06-29-09 22:46
Research Compliance Specialist Senior – Flint, MI
For full posting and to apply, visit: http://www.umich.edu/~jobs/
Job ID: 31956
Market Title: Research Compliance Specialist Senior
Department: University of Michigan-Flint, Office of Research
Salary Range: $45,000-$50,000
End Date: This posting will close on July 15, 2009 (at 11:59 pm)
Develop and present educational materials to the UM-Flint research community to increase awareness of, and compliance with human subject, laboratory animal, or biologically infectious agent regulations. Resolve questions about the application process and applicable regulations. Interpret regulations and develop internal guidance documents for use by review staff. Conduct fact-finding and oversee efforts leading to the resolution of study-specific complaints. Integrate lessons learned into educational materials. Conduct highly competent review of applications for compliance with regulations, contact principal investigators to resolve inconsistencies and/or clarify content of the application prior to review by the compliance oversight committee. Communicate decisions of the compliance oversight committee to the principal investigator. Assist in the development, implementation, and administration of compliance program components including protocol and consent form review, record keeping, monthly and annual reporting, program evaluation and other compliance issues that meet the applicable government and local regulations and the institution's policies and practices. Maintain confidentiality regarding subjects, records, and review of issues. Train principal investigators and administrators in the preparation of compliance protocol applications for human subjects, laboratory animals, or infectious agents.
Bachelor's degree or equivalent and 5 years or more related experience; Master's degree preferred. Requires significant knowledge of complex Federal, State and Local regulations. Excellent written and oral communication skills, strong interpersonal skills, ability to manage multiple deadlines and prioritize competing goals; facility with word processing, electronic communications, and web-based project management systems. IRB Management Certification highly preferred. Employees in this classification typically analyze, compare and evaluate various courses of action and have the authority to make independent decisions on matters of significance, free from immediate direction, within the scope of their responsibilities. Primary activities and decision making authority are predominantly performed independently affecting business operations to a substantial degree. Under FLSA, incumbents in this position meet the criteria for exempt status.
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