In House Clinical Research Associate
Current• Performs investigator recruitment activities utilizing phone scripts and questionnaires, if applicable, study site materials and other tools to for use in evaluating investigative sites• Utilizes the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked• Performs essential document collection, review, in start-up, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines• Supports investigators and investigative staff in fulfilling obligations with regard to local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements• Performs study tracking via CTMS or sponsor designated system to ensure that the study files are current, accurate and complete• Documents site and Sponsor contact and study interactions in a timely and professional manner• Assists with resolution of investigational site/data queries• Liaises with project team members regarding study site issues• Provides quality review of the informed consent template• Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other requirements stipulated on the study• Follows up with sites for trial invoices and ensures CTMS is accurately updated to allow the timely processing of Investigator Payments• Performs other duties as assigned
