Clinical Research Associate II / Senior Clinical Research (CRA) (m/w/x) Germany
CTI · Ulm, Baden-Wurttemberg, DE
What You'll Do: - Serve as main CTI contact for assigned study sites - Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV],...
Job description
What You'll Do: - Serve as main CTI contact for assigned study sites - Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCP - Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection - Collect, review and track essential/regulatory documents - Participate in and complete all general and study specific training as required - Participate in investigator, client and project team meetings; may include presentations - Create and implement subject enrollment strategies for assigned study sites - Ensure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materials - Perform site management activities and provide ongoing updates of site status to Clinical Project Manager - Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan - Utilize systems and reports to track subject status, subject case report form (CRF)...