Reviewer II

Job not on LinkedIn

đŸ”„ 3 minutes ago

🌐 Romania, Bulgaria – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

✹ Reviewer

đŸ‘» Ghost score 10%

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Logo of Fortrea

Fortrea

10,000+ employees

đŸ„ Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare ‱ Biotechnology ‱ 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.

📋 Description

‱ Review and implement relevant study-specific plans describing required expectations for assigned tasks ‱ Support system compliance and system data entry, as applicable ‱ File required task-related documentation in the Electronic Trial Master File (eTMF) ‱ Review initial/amended Country/Site ICFs in compliance with Sponsor requirements, local regulatory requirements and Good Clinical Practice (GCP) guidelines ‱ 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

🎯 Requirements

‱ 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) ‱ Fortrea may consider relevant and equivalent experience in lieu of educational requirements ‱ Strong knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines ‱ 3 years’ work experience in clinical research ‱ Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) ‱ Excellent written and oral communication skills ‱ Excellent organizational skills ‱ Excellent proof-reading skills ‱ Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects

đŸ–ïž Benefits

‱ EEO & Accommodations request information provided

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