ICF Reviewer II

🔥 0 minutes ago

🌐 Romania, Bulgaria – Remote

🇷🇴 Romania – Remote 🇧🇬 Bulgaria – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

✨ Reviewer

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 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 Country/Site Informed Consent Form to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines • Review Patient Recruiting materials (Advertisements) to assure compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines • File Informed Consent Form, Patient Recruiting materials, and Investigator Package approval documentation in TMF and eTMF • Review protocol amendment to reconfirm completeness and to assure compliance with Good Clinical Practice (GCP) guidelines • Review revised Core Informed Consent Forms to reconfirm compliance with sponsor requirements, local regulatory requirements, and Good Clinical Practice (GCP) guidelines • Provide input for Corrective and Preventative Actions (CAPAs) related to Document Review activities including Informed Consent Form Review, Patient Recruiting material Review and Investigator Package Review • Perform all other duties as needed or assigned

🎯 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 • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines • 2 years’ work experience in clinical research • Previous interaction with operational project teams preferred • Computer proficiency in MS Office (Word, Excel, PowerPoint, Access, Outlook e-mail and internet services) • Good written and oral communication skills • Well-developed organizational skills • Excellent proof-reading skills • Good time management skills with ability to consistently prioritize workload to accommodate multiple tasks and projects • Ability to work independently within a flexible team environment • Accuracy and Attention to detail • Analytical and problem-solving skills