Receives direction from principal investigator, supervisor, or other staff involved in research protocol(s). Interacts with various departments within the institution. Works cooperatively with other investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and ensure efficient completion of research studies. Position Overview: Coordinates non-therapeutic (i.e. minimal risk, survey, chart review) clinical research protocols with direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. May assist in complex (i.e. interventional, therapeutic, greater than minimal risk) studies with direction but does not have overall responsibility for these studies. Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. Recognizes adverse events, protocol deviations, and other unanticipated problems and reports appropriately. Collects, abstracts, and enters research data. Performs administrative and regulatory duties related to the study as assigned. Some travel may be required. Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; Institutional Review Board (IRB) submission; and communication with study sites and/or federal agencies regarding study status changes. Participates in other protocol development activities and executes other assignments as warranted and assigned.
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Industry
Hospitals
Education Level
High school or GED