Clinical Trials Assistant 2

Primary Responsibilities:

Provide administrative support to clinical projects under direction of line manager, Clinical Research Specialist and/or other designated clinical team members. Assists with general administrative functions as required.

RESPONSIBILITIES
•Assist Clinical Research Specialist (CRS)/In-house Clinical Research Specialist (iCRS), Clinical Research Associates (CRAs)/In-house Clinical Research Associate (iCRA) and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
•Assist the clinical team in 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 CRS/iCRS, CRAs/iCRAs 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 and with required approval.
•May perform assigned administrative tasks to support team members with clinical trial execution.