Senior CRA / Czech Republic Nr ref.: /JOBS.pl Senior CRA / Czech Republic Full-timeJob description Our client- global biopharmaceutical company, is looking for a Senior Site Clinical Research Associate (SCRA) to work home based in Czech Republic (Prague). As a SCRA you will manage activities of clinical investigative sites ensuring successful execution of the study protocols. You will be responsible for complex studies with potentially large numbers of sites requiring oversight of operational issues therefore you will have a proven track record as a SCRA.Responsibilities will include: * Monitors activities conducted by clinical investigative sites. * Plan and conduct investigator and site-staff training * Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase I-IV studies in accordance with applicable regulations, GCP, ICH Guidelines and SOP as well as business processes. * Create site specific and monitoring tools * At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. * Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas * Conduct site closure visit according to the checklist activities listed on the site closure report * Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with project team members.Eligibility/Qualifications/RequirementsTo be eligible for consideration, you will come with: * Minimum 3 years of clinically related experiences working on a CRA position * Current in-depth knowledge and understanding of appropriate therapeutic indications (experience preferably in oncology, gastroenterology, rheumatology and dermatology) * Experience in on-site monitoring of investigational drug or device trials is required * Fluent Czech is required in addition to good English (verbal and written). inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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