Independently coordinates complex clinical research protocols, including interventional and therapeutic studies greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. Ensures compliance with regulatory laws and institutional guidelines; collaborates with the research team to assess protocol feasibility and management; implements protocols following IRB approval; and provides information for progress reports as appropriate. Screens, enrolls, and recruits participants; coordinates schedules and monitors research activities and participant involvement; identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems; and manages, monitors, and reports study data to maintain quality and compliance. Provides departmental education and training and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, proofing, and content verification; coordinating study logistics such as blood collection kits, data collection booklets, and use of the CRU; communicating with study sites and/or federal agencies about study status changes; preparing and submitting federal and institutional IRB documents; and providing consultative expertise on regulatory and policy requirements. Accurately incorporates investigators’ scientific data into protocol documents and associated procedures consistent with internal and external policies and regulatory requirements. Participates in other protocol-development activities and completes other assignments as warranted. Cognitive testing is a required part of the position. Prior experience is not required, but the coordinator should be comfortable learning to administer standardized cognitive assessments as a regular responsibility. Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.
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Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED