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Clinical Research Associate (Monitoring)
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- The Clinical Research Associate (CRA) advises and assists University of Minnesota faculty members in their preparation, conduct, and management of clinical trials.
- The Code of Federal Regulation (CFR), Good Clinical Practice (GCP) guidelines, and National Institutes of Health (NIH) research rules set standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials.
- Most monitoring will occur remotely or on the UM Minneapolis/St. Paul campus but off-site monitoring in the Twin Cities Metro area occasionally happens.
- Is responsible for monitoring to the standards of the FDA Code of Federal Regulations, ICH GCP guidelines, the NIH, the Human Subjects Protection Program and other university committees, such as IRB;
- Is responsible for scheduling and performing study start-up, interim and closeout visits; - monitors subject consent and safety, protocol adherence, data integrity, regulatory documents, drug and device records, training and authorization records, eligibility and enrollment and overall conduct of the study;
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