Location: Tarrytown, NY

Duration: 06 Months+

Description:

Reports to a Sr. Clinical Study Manager and assists in the preparation and execution of clinical study tasks, including: documentation (clinical plan, protocol and report), site initiation, monitoring, and completion of clinical studies for verification and/or validation of in vitro diagnostic products. 

Ensures adherence to Good Clinical Practice (GCP) and company standard operating procedures for conducting clinical studies. With minimum supervision, completes all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical studies including collection, timely review and analysis of generated data. Communicates with study investigators and site personnel regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators and institutions with access to specimens needed in clinical studies.

Coordinates with biostatisticians and data managers to manage incoming clinical site data and may assist in the design and maintenance of study databases. Provides up-to-date reports on clinical study progress. May negotiate site specific study budgets, and initiate/oversee contract origination, compliance approval, and execution.