The main task of the CRA is to act as a link between sponsor, CRO and trial site as well as to perform quality control of clinical trials. The focus is on clinical studies conducted in-house at bioskin or in the Northern German region.
Perform all kind of the monitoring visits (site selection, initiation, periodic and close-out visits) as well as remote monitoring
Generation and updating of monitoring plans and site initiation presentation
Evaluating the quality and integrity of site practices
Act as contact for clinical trial suppliers and other vendors as assigned
Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
Close cooperation with the different departments in-house at bioskin as well as freelance CRAs
Compliance with protocol, GCP/ICH Guidelines
Min. 2 years of the clinical monitoring experience (preferred Dermatology)
Degree in a scientific or medical discipline or equivalent
Very good knowledge of Good Clinical Practice/ICH Guidelines
Proven ability to work independently in a fast-paced environment
Excellent communication, interpersonal, and organizational skills
Fluency in German and a high level of English language
located in Hamburg
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Originally posted by Eurofins. View original posting
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