Clinical Research Assistant
Current• Maintaining systems to coordinate and track study conduct, site performance, and timelines - this is crucial for ensuring that the study is conducted efficiently and effectively.• Assisting with the preparation, submission and/or tracking of regulatory materials - this is essential for ensuring that the study complies with all applicable regulations and guidelines.• Reviewing study documents, operational policies, and procedures; coordinating internal and external reviews; and tracking key decisions - this is important for ensuring that the study is conducted in accordance with standard operating procedures and best practices.• Maintaining shared filing systems (e.g., SharePoint, MS Teams); collecting, reviewing, and filing essential documents (e.g., in the study-specific electronic Trial Master File [eTMF]) - this is essential for ensuring that all study documents are organized and easily accessible.• Communicating directly with various research sites, providing technical assistance to research sites and study staff, including review of materials, site updates, subject payment and query resolution, under supervision - this is important for ensuring that research sites have the support they need to conduct the study effectively.• Prepares patient documentation ahead of appointment; Ensures patient files and source documents are ready for their visit.