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DSMC Compliance Auditor

Bloomington, IN

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Summary Assist with the implementation and coordination of safety auditing as part of the Data and Safety Monitoring Committee (DSMC) at the IU Simon Cancer Center. This role is a risk management role for the IU Simon Cancer Center and will ensure adherence to all research standards set forth by the International Council on Harmonisation (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA), the Human Subjects Office (HSO), **MEMBERS ONLY**SIGN UP NOW***., National Cancer Institute (NCI) and other pertinent regulatory agencies, and adheres to institution Standard Operating Procedures. Primary functions will include Cancer Center-wide auditing of serious adverse events, reportable events, and deviations, DSMC management, as well as auditing a subset of NCTN trials to meet the requirements of the IUSCC DSMP. He/she will also participate in the development, coordination and support of QA and compliance functions and activities, including short-range planning and input for long-range Compliance Team planning. Required Qualifications REQUIRED: Bacheloru2019s Degree, plus 3 yearsu2019 human subjects research-related experience. Preferred Qualifications Familiarity with MS Office, Oncore and Cerner. Working Conditions / Physical Demands May require some moving of charts. Must be able to remain in a stationary position for long periods of time.

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