Clinical Research Specialist I (NE) - Infectious Disease

Job description

Clinical Research Specialist I (NE) - Infectious Disease - ( 260003DU ) Description A Brief Overview Under the direct supervision of the Principal Investigator and senior study staff, assists with the coordination and implementation of assigned clinical research trials. What You Will Do: - Assists with the submission of related documents to the appropriate regulatory review committees and maintenance of regulatory files. (10%) - Performs assigned activities related to clinical research studies including but not limited to: Screening participants for eligibility and recruitment, obtains informed consent, educates participants regarding study requirements and completes source documents and case reporting forms. (30%) - Responsible for in-depth knowledge of protocol requirements and Good Clinical Practice (GCP) guidelines. (20%) - Documents, records and assimilates accurate participant records and study records to ensure documentation compliance with sponsor guidelines, standard operating procedures (SOP) and internal and external regulatory agencies. (20%) - Establish and maintain communications with Investigator, Sponsor and internal constituents. (10%) - Performs other related duti...