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Principal Investigator
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- Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
- Immediately report Serious Adverse Events (SAEs)or any abnormalities affecting participants safetyto sponsors and to the IRB as required by study specific reporting guidelines
- Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.
- Ensure that the IRB is provided with a copy of the Investigators brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
- During the study, ensure the IRB is informed of any changes to the protocol, Investigators brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems
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