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Labcorp Drug Development is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries. Are you ready for the next step in your career? We are currently recruiting for a Clinical Research Associate I in Brazil. Role description: - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review - Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy - Travel, including air travel, may be required and is an essential function of the job. - Manage small projects under direction of a Project Manager/Director as assigned - Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned - Review progress of projects and initiate appropriate actions to achieve target objectives - Organize and make presentations at Investigator Meetings - Act as contact for clinical trial supplies and other suppliers (vendors) as assigned - Responsible for all aspects of registry management as prescribed in the project plans - Conduct, report and follow-up on Quality Control Visits (CQC) when requested - Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned Requirements: - A minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc) - Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries - Thorough understanding of the drug development process - Fluent in local office language and in English, both written and verbal
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