April Baker Email and Phone Number

Office of Research Integrity and Compliance - Development and implementation of a post-approval monitoring program; supervises and evaluates processes and procedures of regulatory compliance coordinators working with the Institutional Review Board.

Responsible for the day-to-day operations of the Institutional Review Board. Maintains protocol and committee meeting records subject to review by the Office of Human Research Protections and the Federal Food and Drug Administration for approximately 800 research studies involving human subjects. Provides consultation to faculty regarding their research proposals to ensure compliance with all Federal, State, and local regulations governing research involving human subjects. Active involvement with policy development and writing policy relating to IRB activities. Reports directly to the Director of the Office of Research Integrity and Compliance. Supervises two FTE Research Compliance Coordinators and one FTE Sr. Administrative Assistant.

Responsible for maintaining regulatory documents for approximately 75 pharmaceutical company-sponsored cancer research studies being conducted by faculty in the section of Hematology/Oncology. Review and submit study proposals to the Institutional Review Board and other federally mandated research review committees for approval. Responsible for all correspondence regarding research proposals in regards to queries from the various committees in order to obtain approval and maintain approval throughout the life of the research. Interacts closely with representatives from pharmaceutical companies, independent contract research organizations, the Food and Drug Administration, the National Cancer Institute, physicians, and nurses. Enforces and follows all Federal, State and local regulations governing clinical research involving human subjects. Regular consultation with physicians regarding regulatory issues associated with their studies. Reports directly to the Administrative Manager of the Cancer Research Center Protocol and Data Management Office.

Worked with Pharmaceutical company sponsors to open research studies for patient enrollment for the Cancer Research Center. Submitted all regulatory correspondence for studies to the U of C Institutional Review Board FDA-required documentation to the sponsors.

Responsible for day-to-day operations of the Biological Sciences Division Institutional Review Board. Organized and attended meetings. Composed follow-up written communication of meeting results for faculty investigators regarding their research proposals. Maintained committee meeting records subject to review by the Food and Drug Administration for approximately 1,700 research studies. Provided consultation to faculty regarding their research proposals to ensure compliance with all Federal, State, and local regulations governing research involving human subjects. Reported directly to the Associate Director of Regulatory Compliance

of Regulatory Compliance Promotion to continue primary responsibility for day-to-day operations of the Biological Sciences Division Institutional Review Board. Provided secondary support to three other federally mandated committees charged with the review of research involving biohazards, animal, and radioisotope research. Continued organization and attendance of monthly committee meetings. Supervisory responsibilities of three clerical staff employees. Reported directly to the Associate Director of Regulatory Compliance.