What you will be doing: Management Clinical Trials according to the protocol and ICH GCP, standard operation procedures and monitoring plan. Knowledge and understanding of the protocol and CRF content Keeping contact with the Investigator. Supporting sites with all issues concerning study. Providing information to investigators about: protocol principles, study timelines, enrolment expectations and proposed fee. Preparing and performing Initiation Visit and Monitoring Visit according to the GCP and monitoring plan. Preparing Institution and Investigator fees documentation. QUALIFICATIONSA life science / healthcare related degree or equivalent work experience.
Minimum 1 year of independent monitoring experience (mandatory)Solid understanding of clinical trial design, trial execution and operations. Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations. Expertise in communication, managing multiple priorities and computer literacy. Proven people management skills with demonstrated expertise in working in a team. Fluency in English as well as Polish.
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