Quality Assurance Manager

3 weeks ago

Providence, Rhode Island, United States InsideHigherEd Full time
About the Position

The Quality Assurance/Quality Improvement Manager is a key member of the Office of Research Integrity's (ORI) QA/QI program team. This role is responsible for developing and maintaining a post-approval monitoring program for the unified human research protections program at Brown University and associated health systems.

Key Responsibilities
  • Develop and implement a post-approval monitoring program to ensure compliance with federal regulations, institutional policies, and AAHRPP standards.
  • Conduct monitoring and auditing activities, including site visits, to ensure compliance with regulatory requirements.
  • Evaluate program operations and work with stakeholders to develop improvement initiatives.
  • Coordinate and conduct post-approval monitoring of human subject research activities for compliance with IRB-approved protocols.
  • Generate visit reports for the IRB and other stakeholders, and work closely with the HRPP/IRB to compile, draft, and submit regulatory reports to agencies or sponsors, as needed.
Requirements
  • Bachelor's degree and 5+ years of related experience or equivalent combination of education and experience.
  • Working knowledge of federal regulations protecting human subjects.
Preferred Qualifications
  • Experience working in an HRPP office within an academic or clinical hospital/research setting.
  • At least 3 years of related experience working in a research compliance setting, either in administration or conducting research.
  • Experience with post-approval monitoring activities.
Competencies
  • Thorough understanding of current federal and State regulations regarding human subjects research and ethical principles, Institutional policies, and integrated HRPP SOPs.
  • Ability to practically apply federal and state regulations as well as institutional policies to research submissions under review.
  • Ability to handle monitoring and auditing activities, including site visits, independently and competently.
  • Ability to handle confidential documents and sensitive information.
  • Ability to multitask and prioritize workloads.
  • Excellent interpersonal, oral, and written communication skills.
  • Ability to work independently and use judgment and discretion in potentially controversial matters.
  • Ability to work with limited supervision and serve as a strong team member.
  • Participation in continuing education and national and/or regional organizations devoted to promoting research ethics and the protection of human subjects.
  • Proficiency in Huron electronic IRB submission system, Microsoft Office applications, Google platforms, Adobe and other commonly used software.
  • Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment.

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