Essential Functions: POSITION PURPOSECoordinate the administration of the Institutional Review Board (IRB), and other regulatory activities and operational procedures involved with reviewing and approving research protocols. Function as a liaison for multiple review boards, investigators, granting agencies and federal regulatory agencies. Provide structured, formal training and orientation to Research Compliance Administrators as well as ad hoc guidance as necessary. ESSENTIAL FUNCTIONS-Review and process new and continuing research protocols for submission to appropriate research review boards. Resolve protocol submission errors/problems with investigators and key personnel. Direct unresolved issues to committee chair.-Develop and deliver a formal training program for Research Compliance and Administrators (RCA). Develop curriculum, conduct sessions and discuss progress with management to determine next level of training. Serve as a resource and provide ad hoc guidance to RCAs as necessary. -Coordinate and attend IRB/committee meetings. Serve as informational resource for regulatory and policy issues. Maintain record of committee decisions and activities. Create condition(s) of approval directives for investigators resulting from meetings to ensure policy and regulatory compliance.-Assist faculty and research investigators with compliance and regulatory issues. Address questions resulting from meeting the conditions of approval directives. Provide procedural direction to ensure conditions of approval directives are addressed appropriately.-Review investigator responses from IRB meeting conditions of approval directives and determine if issues are properly addressed. Generate approval letter or direct unresolved issue to committee chair as appropriate.-Review adverse events and protocol violations and direct to committee chair, individual IRB, institutional officials, and regulatory agencies as appropriate. Provide procedural guidance to investigators when adverse events or violation is minor to ensure policy and regulatory compliance is maintained.-Conduct, monitor and coordinate special projects as assigned. Prepare a wide array of statistical and administrative reports, summaries and questionnaires regarding department activities.-Represent the department and serve as liaison to outside individuals, professional groups and administrators to interpret administrative procedures and policies and to disseminate information on department activities.-Coordinate audits by federal regulatory agencies of research protocols and the regulatory committees (Food and Drug Administration, Office of Human Research Protection, Office for Laboratory Animal Welfare, U.S. Department of Agriculture, etc.)-Assist and coordinate the development of institutional policies, procedures and manuals concerning the program for protecting human participants, animals and other regulatory activities.-Conduct post approval monitoring visits of the research to observe and document research conduct and regulatory compliance. The monitoring reports will be submitted to the Human Research Protection Program Administration and to the Institutional Review Boards for evaluation and determination of further action.--Perform related work as assigned.
Qualifications: MINIMUM QUALIFICATIONSGraduation from an accredited college or university supplemented by coursework in research, business administration, or related field and/or an equivalent combination of education and/or experience.-Considerable knowledge of pertinent federal regulators and state and local laws, e.g., Office of Human Research Protection, Food and Drug Administration, Office of Laboratory Animal Welfare, Office of Research Compliance and Assurance, Health Insurance Portability and Accountability Act, etc.-Some knowledge and experience with University policies, procedures and practices surrounding the approval of research.-Some knowledge of pharmaceutical and drug agency research requirements.-Reasonable knowledge of and experience with PC and computer-based applications.-Some supervisory experience required.-Ability to communicate effectively with others.-Strong analytical and problem-solving skills.-Ability to establish and meet deadlines, work under extreme pressure, and function independently.-Typically incumbents may have held a Research Compliance Administrator or regulatory compliance position.
Internal Number: 76_207000
About Wayne State University
Founded in 1868, Wayne State University is a nationally recognized metropolitan research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Wayne State?s main campus in Midtown Detroit comprises 100 buildings over nearly 200 acres; its five extension centers offer higher education to people throughout Southeast Michigan. Wayne State is dedicated to preparing students to excel by combining the academic excellence of a major research university with the practical experience of an institution that by its history, location and diversity represents a microcosm of the world we live in. Reflecting its location and the excellent international reputation of its graduate schools, particularly in the sciences, Wayne State boasts the most diverse student body among Michigan?s public universities. Its students represent 49 U.S. states and more than 60 countries.