(AIC), 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. Position duties require the application of highly specialized skills, which can be acquired through a combination of job-related training and considerable on-the-job experience.

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.

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.

Reasonable 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 staff supports position, e.g., Administrative Assistant.