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Clinical Research Quality Assurance Monitor

Req # 32867 Job Location Los Angeles, California - US
The Clinical Research Quality Assurance Monitor will verify that the rights and well being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents; and that the conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with applicable regulatory requirements. The monitor, in accordance with the sponsor’s requirements, should ensure that the trial is conducted and documented properly by carrying out the following activities when relevant and necessary to the trial and trial site. Qualifications: BA or BS or equivalent experience in health related field with coursework emphasizing research methods and biological sciences. The CTM should be appropriately trained and should have the scientific and/or clinical knowledge needed to monitor the trial adequately. A CTM’s qualifications should be documented. Three years medical clinical trials experience. One year clinical trials monitoring experience in Hematology/Oncology preferred. License, Registration or Certification Required: Clinical Research Certification through SOCRA or ACRP. Skills: The CTM should be thoroughly familiar with investigational protocols, informed consents, SOP, GCP and the applicable regulatory requirements. Up to 30% travel required. Founded in 1901, Children’s Hospital Los Angeles is one of the nation’s leading children’s hospitals and is acknowledged worldwide for its leadership in pediatric and adolescent health. Children’s Hospital Los Angeles is one of only seven children’s hospitals in the nation – and the only children’s hospitals on the West Coast – ranked for two consecutive years in all 10 pediatric specialties in the U.S. News and World Report rankings and named to the magazine’s “Honor Roll” of children’s hospitals. Children’s Hospital Los Angeles is a premier teaching hospital and has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. EOE/AA
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