Assistant Vice President for Research Regulatory Compliance

Assistant Vice President for Research Regulatory Compliance

Job ID12195
Location
Case Main Campus
Full/Part TimeFull-Time
Regular/TemporaryRegular

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. The
Assistant Vice President is responsible for developing and implementing a long-range strategic plan to enhance operations of all research regulatory committees, so they adhere to all federal, state, and local regulations while supporting faculty to secure approvals in a timely fashion. The assistant vice president plays an integral role within the university’s Research Administration leadership team and will serve as an advisor to senior leadership on matters related to 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 discovered. Develop processes to ensure that all university investigators are compliance with Clinical Trials.gov reporting requirements. Serve as member of the University Compliance Committee and various other university committees to represent the university office for Research Administration and Technology Management. Develop and manage the Quality Improvement Review Program for the HRPP. Provide oversight to the program administrator for the administrative, training and compliance and business processes of the IRB Quality Improvement Review Program. Develop evolving policies and procedures for the audit and oversight of research conducted under regulatory requirements. Provide oversight of the audits carried out by the manager. Oversee Quality Improvement Review Program goals to meet national accreditation standards to facilitate and maintain the accreditation of the HRPP. Research and interpret trends and new developments in the federal regulatory and compliance area pertaining to investigator conduct of research. Develop strategies to enable the university to successfully adapt to changes. Regularly communicate and disseminate appropriate information. (15%)
This position serves as the lead for the strengthening of our relationship with our affiliate hospitals regarding regulatory compliance to develop processes to ensure that faculty are able to conduct research across institutions efficiently. Serve as the Administrator for the IAC and acts on behalf of the IAC Chair in his/her absence. Provide strategic planning mechanisms to ensure utmost function of the IRB Advisory Committee. Help to provide expertise in human subjects research and promote harmonization between the IRBs and their common processes. Strategically plan working relationship with faculty members, staff and students in promoting their research and moving it forward in the CWRU IRB SpartaIRB system and utilization of the Reliant Review Program. (15%)
Direct institutional efforts to meet compliance needs. Serve as an expert for executive directors as they conduct investigations of allegation of regulatory non-compliance. Work with the executive directors and investigators to report compliance matters to the appropriate agencies. Acts as a liaison between university and regulatory agencies. Advise executive directors on various definitions for non-compliance. Notify the vice president and associate vice president for research if a study is federally funded and the regulatory committees find events to be a matter of serious and/or continuing non-compliance. Support the crafting of the letter to regulatory agencies. Directly report to appropriate Institutional and federal government officials as required by federal regulations. Work with senior vice president and associate vice president for research as well as the associate deans for research to establish good working relationships and advise them on compliance matters. Act as regulatory expert regarding compliance matters and give advice regarding the federal regulations, state laws, and local policies. Serve as member of the university Compliance Committee and various other university committees to represent the university office for Research Administration and Technology Management. (15%)
Develop a national presence for CWRU in the research regulatory community. See roles in national organizations and actively pursue opportunities for engagement with other university leaders. (5%)

NONESSENTIAL FUNCTIONS

Perform other duties as assigned. (