Experience

Northwestern University

• United States
• Higher Education
• 700 & Above Employee

• Senior IRB Analyst - Institutional Review Board at Northwestern University

  • Aug 2018 - Present

  • Ensure that IRB operations meet legal and regulatory requirements and are in compliance with ever more complex federal, state, and local regulations.• Independently determines adequacy of IRB applications and level of technical review required. • Provides regulatory, ethical, and method advice to individual faculty and staff in preparation of applications for research proposals involving human subjects and consent documents. • Prepare auditable institutional and federal technical documents needed for IRB panels’ review and recommendations.• Reviews request to amend or modify approved protocols and makes determination about which requests require full IRB review and which can be reviewed using an expedited process. • Prepare agenda for each panel meeting based on knowledge of scientific aspects of the research submissions to be reviewed, and well as regulatory requirements and the expertise/role of each panel member.• Responsible for ensuring compliance with quorum and voting requirements for all IRB approvals deliberated at convened meetings. • Train IRB Members, Analysts and support staff on the technical and administrative process required for human subject research. • Reviews complex proposed research protocols to identify potential problems and make recommendations for their modifications as appropriate. • Writes documents that are subject to professional and technical audit that convey IRB deliberations and contingencies for approval of research activities involving human subjects. Show less

• Senior Regulatory Coordinator- Robert H. Lurie Comprehensive Cancer Center

  • Jan 2001 - Aug 2018

  • Team Leader for two Senior Regulatory Coordinators and one Junior Regulatory Coordinator.• Develop research subject informed consent forms for Hematology/Oncology clinical studies for pharmaceutical, institutional, and cooperative group studies. • Prepare and coordinate research documents for review by the Institutional Review Board (IRB) including amendments, revisions, investigator brochures, subject recruitment materials and terminations. • Complete extensive, detailed IRB forms summarizing all aspects of a research study. Trained and have over ten years of experience with the NU eIRB electronic submission process. • Serve as liaison to affiliate institutions, study sponsors, study coordinators, and oversight agencies.• Manage the CTO database (NOTIS) assuring the completeness and accuracy of regulatory data including form submission dates, approval dates, and upload approved consent forms and protocols. • Maintain confidentiality and effective working relationships with clinical physicians, affiliated centers, pharmaceutical companies, IRB and co-workers while fostering a team-oriented environment.• Recipient of the IRB 2010 Regulatory Coordinator of the Year award. Show less

• Assistant Director - Office for the Protection of Research Subjects (OPRS)

  • Apr 1996 - Jan 2001

  • Served as liaison between the Institutional Review Board (IRB), Animal Care and Use Committee (ACUC), Center for Comparative Medicine (CCM), investigators, research staff and co-workers to ensure that sensitive and confidential issues are concisely communicated, negotiated, resolved, and properly documented in accordance with applicable regulations. • Developed office policies and procedures to improve customer service and maintain confidentiality, supervised staff, and maintained oversight of the OPRS web site. • Re-engineered the committee review process and project submission procedures to streamline the process and maximize productivity. • Created Northwestern University ACUC’s procedural guidelines for the federal government, defining the department’s responsibilities and objectives and ensuring research integrity. • Maintained the ACUC and IRB database to accurately generate timely letters and reports for faculty members, research staff, committee members, administrators and federal regulatory agencies. • Recorded the minutes of complex committee meetings and composed a large volume of technical analytical correspondence based on committee deliberations. Show less

• Program Assistant - Center for Comparative Medicine (CCM)

  • Oct 1994 - Apr 1996

  • Processed orders and coordinated room allocations and transfers, adhering to strict delivery time lines. • Provided administrative support, including reception, customer service, data entry, and other office duties.