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Research Compliance Specialist - Ann Arbor, United States - University of Michigan
Description
How to Apply
A cover letter and resume are required for consideration for this position; include the cover letter as the first page of your resume. The letter should specifically address your interest in this position and outline relevant skills and experience.
Summary
The Research Compliance Specialist Senior role is located within the Institutional Review Board Coordinated Services and Practices Unit (CSP) of the Human Research Protections Program (HRPP) and provides direct support to the Health Sciences and Behavioral Sciences IRB (IRB-HSBS) to evaluate and investigate allegations of human participant research noncompliance, concerns, or complaints. This role will primarily provide support related to social, behavioral, and education research activities. This is a hybrid position (includes both remote and in-office work hours) that reports to the Director of the CSP.
Responsibilities
This role performs the following duties:
Conduct reviews and fact-finding related to reports of alleged human participant research noncompliance.
Evaluate study team activities as directed by HRPP or Institutional Review Board (IRB) leadership.
Generate reports on the status and results of fact-finding or evaluating activities for HRPP leadership, IRB leadership, or other identified individuals. Prepare written documentation of compliance matters to meet regulatory or institutional requirements. Track and maintain records of noncompliance issues.
Evaluate and follow-up on concerns or complaints about research activities from research participants, the research community, the University of Michigan Compliance Hotline, and the community at large. Track and maintain written documentation of concerns or complaints.
Provide guidance to researchers on regulatory requirements related to their human participant research activities.
Create agendas and coordinate meetings related to research compliance.
Assist the HRPP with readiness for regulatory (e.g., OHRP, FDA, OCR) and accreditation (e.g., AAHRPP) audits, site visits, or inspections.
Maintain up to date knowledge of state and federal regulations as well as policies, guidelines and ethical codes related to research compliance.
Support special initiatives, including policy/procedure analysis and development of internal guidance documents and education activities related to noncompliance issues, concerns, or complaints.
Assist with additional related responsibilities as assigned by supervisor.
Required Qualifications
Bachelors degree or equivalent in education and experience.
5 years or more of professional experience in research compliance or research administration.
Knowledge of federal, state, and local human research regulations, policies, and guidance and their direct application to the research environment.
Considers all relevant factors and uses appropriate decision-making criteria and principles.
Uses rigorous logic and methods to solve difficult problems with effective solutions.
Able to work independently and responsibly with minimal supervision.
Willing to enter and follow a confidentiality agreement related to information about participants, researchers, and other restricted content.
Works cooperatively with others across the organization to achieve shared objectives.
Is effective in a variety of communication settings: one-on-one, small, and large groups, or among diverse styles and position levels.
Seeks to understand different perspectives and cultures; Is sensitive to cultural norms, expectations, and ways of communicating.
Desired Qualifications*
Knowledge of social, behavioral, educational, or health sciences research methodologies.
Experience monitoring or auditing research.
Knowledge of AAHRPP accreditation standards.
Additional Information
A higher salary may be considered for exceptionally qualified applicants.
Background Screening
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.
Application Deadline
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.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.
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