Clinical Research Associate I / II

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🕒 May 6

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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

• Support the management of clinical trial sites in compliance with Fortrea SOPs, ICH‑GCP, study protocols, and sponsor requirements, with appropriate supervision • Assist in the preparation and conduct of site monitoring activities, including site initiation, routine monitoring, and close‑out visits, ensuring patient safety and protocol adherence • Perform source data verification (SDV), support query resolution, and review eCRFs to help ensure data quality and completeness • Maintain and update essential trial documentation in eTMF and sponsor systems to support inspection readiness • Support investigational product (IP) tracking and accountability checks in collaboration with the study team • Collaborate with cross‑functional teams and escalate issues appropriately, contributing to site performance, quality, and timelines.

🎯 Requirements

• University or college degree in life sciences, nursing, pharmacy, or a related field • Entry‑level to 1 year of experience in clinical research, including internships, trainee roles, or up to 12 months of onsite monitoring experience • Basic understanding of ICH‑GCP guidelines and clinical trial processes • Strong attention to detail, willingness to learn, and ability to follow established procedures and documentation standards • Fluency in German and English, both written and spoken • Comfortable using clinical systems and tools, with openness to travel as required for site visits.

🏖️ Benefits

• Flexible work model • Competitive benefits • Formal training programs • Modern clinical systems • Continuous learning opportunities