As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Fortrea 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 II in Chile. 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 Fortrea 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 Fortrea 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 - 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 1 year of experience in a related role (e.g. CRA I) - 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 verbalFortrea is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see ourPrivacy Statement.
