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Research Compliance Coordinator

2 months ago

Detroit, Michigan, United States Wayne State Full time
Job Summary

We are seeking a highly skilled Research Compliance Coordinator to join our team at Wayne State University. The successful candidate will be responsible for coordinating the administration of regulatory compliance committees, ensuring compliance with laws, regulations, and institutional policies.

Key Responsibilities
  • Coordinate the administration of Institutional Review Board (IRB), Animal Investigation Committee (AIC), and other regulatory activities and operational procedures.
  • Function as a liaison for multiple review boards, investigators, granting agencies, and federal regulatory agencies.
  • 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.
  • Coordinate and attend IRB/committee meetings.
  • Serve as an informational resource for regulatory and policy issues.
  • Maintain records of committee decisions and activities.
  • 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 letters or direct unresolved issues to committee chairs as appropriate.
  • Review adverse events and protocol violations and direct to committee chairs, individual IRBs, institutional officials, and regulatory agencies as necessary.
  • Provide procedural guidance to investigators when adverse events or violations are minor to ensure policy and regulatory compliance is maintained.
  • Conduct, monitor, and coordinate special projects as assigned.
  • Prepare statistical and administrative reports, summaries, and questionnaires regarding department activities.
  • Represent the department and serve as a 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.
  • Assist and coordinate the development of institutional policies, procedures, and manuals concerning the program for protecting human participants, animals, and other regulatory activities.
Requirements
  • Graduation from an accredited college or university supplemented by coursework in research, business administration, or a related field.
  • Reasonable knowledge of pertinent federal regulators and state and local laws.
  • 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.
Working Conditions

This position is located in a normal office environment. The successful candidate will be required to work independently and under the oversight of a professional and/or management position.