





Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines. • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. • Assist with periodic review of study files for completeness. • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information. • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow. • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation. • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.