Study Coordination : with minimal oversight, coordinate scheduling, preparation, and conduct of complex study visits involving multiple staff and hospital services; assure completion of study assessments and procedures per protocol; obtain informed consent; collect, process, store, and ship laboratory samples; conduct and/or assist with study procedures such as collection of vital signs, ECGs, lumbar punctures, & skin punch biopsies. Regulatory documents & submissions : ongoing maintenance of regulatory compliance and organization of all study documents and materials, adhering to Good Clinical Practice guidelines; independent preparation and submission of regulatory packages to local and central IRBs, including initial submissions, modifications, annual reviews, protocol deviations, and adverse event reports.