A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The Research Ethics and Compliance Office currently seeks an individual to join the Human Research Protection Program (HRPP) as a Compliance Specialist. The individual will work with the HRPP and IRB Directors and staff to manage IRB processes to support multi-site human research, including preparing and tracking of required agreement documentation, communicating with external IRBs, and evaluating and making recommendations of agreement terms and conditions, as necessary. The Compliance Specialist will be responsible for improving business processes and identifying enhancements to the University’s eResearch information management system for human research. The individual will also work closely with other compliance staff on ongoing projects.
Coordinate the review of IRB reliance agreements
Review requests for U-M IRBs to accept or cede IRB oversight and facilitate completion of intake forms and associated reliance documents
Evaluate and make recommendations regarding the terms and conditions of the agreement with outside entities, consulting with the IRB, the Office of the General Counsel, the Office of Research and Sponsored Projects, and others, as needed
Review relevant grant, contract, and protocol materials in eResearch PM/RM systems for details pertaining to terms of the reliance agreements
Track reliance agreements/indemnification materials sent to external sites for signature; respond to questions or requests for additional information
Obtain final U-M signatures on reliance agreements to accept or cede oversight
Create agendas, prepare materials, and staff the weekly IRB Authorization Agreement meeting attended by the HRPP and IRB Directors and staff to evaluate the status and progress on issuing reliance decisions
Maintain the tracking system for reliance agreements, including terminating agreements
Working with the HRPP and IRB Directors and staff, process other regulatory documentation and provide oversight for other HRPP-related functions, including certificate of confidentiality applications and institutional certifications required by NIH for submissions to dbGaP.
Bachelor’s Degree, 3-5 years of relevant employment experience
Familiarity with human subjects regulations
Experience reviewing terms and conditions for research grants and contracts
Ability to multi-task efforts across numerous projects with a high degree of attention to detail
Ability to consider the larger picture of a review process and determine how it involves and affects various departments and agencies within the organization
Ability to work in complex online systems and databases
Strong organizational, writing, communication, interpersonal, and teaching skills.
Ability to work independently with minimal supervision
J.D. degree or other relevant advanced degree
Knowledge of federal, state, and University rules and regulations governing research
Experience managing complex projects
Experience working in an institution of higher education with the demonstrated ability to work with a diverse clientele
Familiarity with eResearch, including the Regulatory Management and Proposal Management
This is a one-year term-limited appointment.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 182935
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.