COVANCE SERBIA - will hire Clinical Research Associates (All Levels) Nr ref.: /JOBS.pl As CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits. Responsibilities: Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP; Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor; Completing Serious Adverse Event (SAE) reporting, processing production of reports; Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned; Interact with internal work groups to evaluate needs, resources and timelines. Assist with training, mentoring, and development of junior employees, e.g. co-monitoring (for CRAs II and SCRAs); Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II and SCRAs). Required education, skills, experience: University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology); Fluency in Czech and English language. Understanding of the clinical trial process; Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries; Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements; Thorough knowledge of monitoring procedures. In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package. For more information and to apply online visit , quoting the appropriate reference number. THERE IS NO BETTER TIME TO JOIN US! Covance is committed to diversity in the workplace and is an equal opportunity employer. Your confidentiality and privacy are important to us. Keywords: Clinical trial, Clinical research, research monitoring, on-site monitoring, remote monitoring, clinical operations, GCP, ICH, SOP, CRO, Clinical Research Associate I, II, Senior CRA, Clinical Research Associate 1, 2, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Monitor, CRA I,II, Senior, CRA 2, CMA, CTA, in-house monitor, in-house CRA, home based, office based, Serbia Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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