Campus Pride Jobs

Job ID 12489 Location Case Main Campus Full/Part Time Full-Time Regular/Temporary Regular Job Description POSITION OBJECTIVE Provide leadership and contributes to strategic planning for research regulatory compliance for Case Western Reserve University. The Assistant Vice President is the strategic leader for developing and maintaining compliant, efficient, and effective policies and processes for research regulatory responsibilities to ensure that our regulatory committees and activities adhere to university and sponsor regulations. The assistant vice president is responsible for developing and maintaining efficient and effective regulatory committees and activities including the Institutional Review Board, the Institutional Animal Care and Use Committee, the Institutional Biosafety Committee, the Institutional Review Entity for Dual Use Research of Concern, the Human Stem Cell Oversight Committee and Export Control. regulatory activities. The assistant vice president will provide leadership and ensure good working relationships with the university's affiliated hospitals, which include University Hospitals Cleveland Medical Center, MetroHealth Medical Center, VA Northeast Ohio Healthcare System, and the Cleveland Clinic Foundation. This position will supervise a regulatory compliance unit of 13 and directly supervise three executive directors and two managers. ESSENTIAL FUNCTIONS Serve as a pivotal member of the Research Administration leadership team. Responsible for overseeing non-financial regulatory responsibilities of the university. Serve as a leader in the development of strategic planning for regulatory compliance in collaboration with leadership in the Office of Research Administration. Serve in an advisory role to the associate vice president for research and the senior vice president for research and technology management. (20%) Direct and oversee the Institutional Review Board, the Institutional Animal Care and Use Committee, the Institutional Biosafety Committee, the Institutional Review Entity for Dual Use Research of Concern, the Human Stem Cell Oversight Committee and Export Control such that these committees provide efficient and effective service to faculty and staff engaged in pursuing research requiring regulatory approval. Facilitate long-range strategic planning, compliance oversight, and development and maintenance of policies and procedures for the regulatory committees. Ensure that sponsoring agencies and university policies and procedures are followed. Stay current on regulatory and legal issues relating to regulatory compliance. (15%) Ensure that each regulatory committee provides faculty and staff information and resources to ensure they are knowledgeable of regulatory requirements. Develop and implement polices for the submission and review of protocols to all regulatory committees so that protocols are reviewed and approved as appropriate in a timely fashion so as not to delay research progress. Develop and disseminate communications that occur with regulatory agencies on the implications of current and proposed policies and procedures. Provide vision and university-wide leadership in establishing and maintaining effective systems of for the management of university regulatory requirements. In collaboration with the Assistant Vice President for Research Integrity and Training develop and continually update comprehensive training for users of all regulatory committees as well as standardized formal training for regulatory committee staff members. (15%) Serve as the University Research Compliance Officer. Analyze current areas of risk to the university with respect to regulatory. Develop and implement a Regulatory Compliance Monitoring Program to systematically monitor research programs to ensure that regulatory requirement is being followed. Work with executive directors to address regulatory issues as they are disc