
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.
🔥 13 hours ago
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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.
• Provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards • Perform routine monitoring and close-out of clinical sites • Maintain study files • Conduct pre-study and initiation visits • Liaise with vendors • Manage study sites according to project plans • Ensure study staff receive proper materials and instructions to safely enter patients into the study • Verify informed consent procedures and protocol requirements comply with applicable regulatory requirements • Verify the integrity of data submitted on Case Report Forms and other data collection tools • Monitor data for missing or implausible data • Manage registries according to project plans and undertake feasibility work when requested • Complete Serious Adverse Event reporting, reports, narratives, and follow-up • Independently perform CRF review, query generation, and resolution using Fortrea or client data management systems • Assist with training new employees through co-monitoring • Coordinate designated clinical projects as a Local Project Coordinator and may act as a local client contact • Perform other duties assigned by management • Travel frequently to client and site locations, including occasional domestic and international travel
• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) • 5+ years of Clinical Monitoring experience • Oncology experience; early phase preferred • 30-50% overnight travel • Comfortable working in a fast-paced environment with strict study protocol and timeline requirements • Ability to adapt to constantly changing priorities • Teamwork and people skills • Ability to work in a technology-based electronic data environment • Ability to sit for extended periods and operate a vehicle safely • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists • Occasional crouching, stooping, frequent bending and twisting of upper body and neck • Ability to access and use a variety of computer software developed both in-house and off-the-shelf • Light to moderate lifting and carrying objects including luggage and laptop computer, maximum 15-20 lbs • Regular and consistent attendance • Varied hours may be required
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