The Human Research Protection Program Specialist serves as the liaison within and amongst the IRB Administration Office, Research Compliance, UH Compliance, the CWRU Conflicts of Interest Department, the UH IRB committees, and the UH research community. The goal of the Human Research Protection Program Specialist role is to support the IRB Specialists and the Research Compliance Specialists in the IRB review and investigative and auditing process to promote research integrity and encourage the safety and welfare of research participants. The Human Research Protection Program will serve as a bridge between research compliance and the UH IRB Administration Office.

What You Will Do

• Maintains a current understanding of Federal, State and local laws, regulations and guidelines as well as UHCMC IRB and UH research policies governing the protection of human research participants. (5%)
• Assists in high level IRB and Compliance related initiatives. Such duties might include:

  * Handling Conflicts of Interest issues (including reporting, tracking, and creating management plans)

  * Administration of the UH Data Safety and Monitoring Committee

  * Facilitating internal quality improvement tasks

  * Supporting AAHRPP accreditation activities

  * Tracking and evaluating internal metrics

  * Assisting with new staff training and development

  * Helping to process and resolve Reportable New Information submission

  * Notify and monitor PIs leaving the institution to ensure a smooth transition

  * Identifying appropriate internal continuing education opportunities (40%)

• Supports the investigative and auditing process for Research Compliance by providing auditing support for larger studies, scribing services for compliance interviews, and reviewing reports, as well as managing emails, notifications, follow ups, and general communication. (30%)
• Functions as a liaison within and between the IRB committees, UH Compliance, CWRU Conflicts of Interest Department, Research Compliance, the IRB
  Administration Office and the Research Community. (5%)
• Provide expert submission/research related consultation, direction, and guidance for other IRB or Compliance specialists, investigators, or study personnel. (10%)
• Participates in special projects / assignments that relate to quality improvement, process improvement, and training. (10%)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.