
10,000+ employees
đ„ Healthcare
đ§Ź Biotechnology
đ Pharmaceuticals
Healthcare âą Biotechnology âą Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
đ„ 3 minutes ago
đ Romania, Bulgaria â Remote
â° Full Time
đĄ Mid-level
đ Senior
âš Reviewer
đ» Ghost score 10%
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10,000+ employees
đ„ Healthcare
đ§Ź Biotechnology
đ Pharmaceuticals
Healthcare âą Biotechnology âą Pharmaceuticals
Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.
âą Review and implement relevant study-specific plans describing required expectations for assigned tasks âą Support system compliance and system data entry, as applicable âą File required task-related documentation in the Electronic Trial Master File (eTMF) âą Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines âą Liaise and follow up with local teams, Start-up Project Managers, and Sponsors to assure timely approval of Informed Consent Forms and meet submission deadlines
âą University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) âą Fortrea may consider relevant and equivalent experience in lieu of educational requirements âą Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines âą 3 yearsâ work experience in clinical research âą Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) âą Excellent written and oral communication skills âą Excellent organizational skills âą Excellent proof-reading skills âą Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects
âą EEO & Accommodations request information provided
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