SrCRA II - 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.We are currently looking for talentedClinical Research Associates to join our team in Romania.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 Fortrea 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 Fortrea 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).Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.