Clinical Research Associate responsible for clinical monitoring and ensuring compliance with study protocols. Engaging in documentation, stakeholder communication, and trial management activities.
Responsibilities
Conduct all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites
Ensure studies are conducted and documented in accordance with study protocols and regulatory requirements
Responsible for monitoring report writing and completion
Support development of study specific documentation related to monitoring activities
Manage investigational supplies and monitor assigned clinical trials
Communicate with assigned clinical sites and other stakeholders about study needs
Participate in meetings and conference calls with project teams
Requirements
Bachelor’s degree or equivalent combination of education and experience
> 5 years of experience as a Clinical Research Associate
Excellent verbal, written communication skills in Serbian and English
Experience with Microsoft Office applications
Electronic data capture (EDC), CTMS, IVRS, and eTMF experience
Knowledge of local law, local regulatory requirements, and GCPs governing clinical trials
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