JobMesh

DSMC Auditor (Open Rank)

University of Colorado Anschutz Medical Campus · Aurora, Colorado, US

DSMC Auditor (Open Rank) ( Job Number: 39172 ) Description University of Colorado Anschutz Medical Campus Department: Cancer Center Working Title: DSMC Audit...

Job description

DSMC Auditor (Open Rank) ( Job Number: 39172 ) Description: University of Colorado Anschutz Medical Campus Department: Cancer Center: Working Title: DSMC Auditor (Open Rank) Position #: 00803329 TBD – Requisition #: 39172 Job Summary: This full-time position will assist with the implementation and coordination of the auditing program as outlined by the CU Cancer Center’s NCI-approved Institutional Data Safety Monitoring Plan to assure the highest quality, safest, and most precisely performed clinical cancer research. Key Responsibilities: Examples of Work Performed by the Clinical Research Auditor (all levels): · Ensures clinical trials at both internal and external sites subject to CU Cancer Center oversight are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCP) & Code of Federal Regulations. · Assures adherence to all research standards set forth by the International Council on Harmonization (ICH) Good Clinical Practices (GCP), Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), University of Colorado Hospital, University of Colorado Denver (UCD), National Cancer I...