Clinical Research Associate or Senior - Romania in Bucuresti

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. Did you know? Labcorp's Clinical Development and Commercialization Services business is now Fortrea in connection with its planned spin-off from Labcorp, which is expected in mid-2023. Fortrea’s spin-off from Labcorp is subject to satisfaction of certain customary conditions. This spin-off will position both organizations for accelerated growth and allow each to focus resources on distinct strategic priorities, customer and employee needs and value creation opportunities. As a provider of phase I-IV clinical trial management, regulatory guidance, patient access solutions and market access consulting, Fortrea will partner with both emerging and large pharmaceutical, biotechnology, device and diagnostic companies to drive healthcare innovation and improve the lives of patients worldwide.Fortrea is looking for problem-solvers and creative thinkers who are passionate about breaking down barriers faced by sponsors of clinical trials, and who are committed to helping transform the development process to get promising life-changing ideas and therapies to patients faster. Join us as we cultivate a workspace where all employees have the opportunity to grow and make impacts on a global scale. For more information and questions related to Fortrea, please visit We are currently looking for talentedClinical Research Associates to join our team in Romania. You would be working within multiple sponsor environment.Responsibilities include:All details of site management as prescribed in the project plansRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasksNegotiation of study budgets with potential investigators and cooperation with Labcorp Drug Development legal department with statements of agreementsSerious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Labcorp Drug Development or client data management systemsRequirements:Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH GuidelinesExcellent understanding of Serious Adverse Event (SAE) reportingAbility to resolve project-related problems and prioritize workload for self and teamYou have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).Labcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp 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 our Privacy Statement.