Coordinates non-therapeutic clinical research protocols, such as minimal-risk, survey, and chart-review studies, under the direction of a principal investigator and/or supervisor and in compliance with regulatory laws and institutional guidelines. May assist with complex interventional, therapeutic, or greater-than-minimal-risk studies under direction, but is not responsible for those studies overall. Screens, enrolls, and recruits participants; coordinates schedules and monitors research activities and subject participation; recognizes and appropriately reports adverse events, protocol deviations, and other unanticipated problems; collects, abstracts, and enters research data; and performs assigned administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, and proofing; coordinating study logistics, such as data collection booklets and use of the CRU; verifying content against institutional and federal standards; submitting materials to the Institutional Review Board (IRB); and communicating with study sites and/or federal agencies about study status changes. The coordinator also participates in other protocol development activities and completes other assignments as warranted.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED