**Job Responsibilities:**

+ 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 clinica...