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. The coordinator works in compliance with regulatory laws and institutional guidelines, collaborates with the research team to assess protocol feasibility and management, and implements protocols following IRB approval. The role 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 research data to maintain quality and compliance. The coordinator also provides education and training to others in the department and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance activities may include managing protocol documents and processes through editing, amendments, proofing, and verification that content meets institutional and federal standards; 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 Review Board (IRB) documents; and providing consultative expertise on regulatory and policy requirements. The coordinator accurately applies investigators’ scientific data to cohesive protocol documents and associated procedures consistent with internal and external policies and regulatory requirements, participates in other protocol development activities, and carries out other assigned duties. This position is 0.80 FTE, or 64 hours per pay period (every two weeks). Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.
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Job Type
Part-time
Career Level
Mid Level
Education Level
High school or GED