
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.
🕒 August 6
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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.
• Coordinate and complete project tasks supporting Project Management for low- to medium-complexity studies, including external site studies • Create and maintain study-specific documents, plans, risk registers, training matrices, and project trackers • Monitor study activity, timelines, training compliance, financial processes, eTMF quality, and CTMS reporting • Organize study meetings, distribute agendas and minutes, maintain project and risk logs, and follow up on action items • Coordinate document filing and timely transfer of documents to the Trial Master File • Support project setup activities, including study IDs, SAS environments, eTMF, and distribution lists • Post and maintain clinical documents, reports, trackers, regulatory documents, metrics, agendas, and minutes in SharePoint or client websites • Serve as sponsor and external-site contact during study maintenance and lead external site calls • Coordinate sponsor and internal training and assist with training and mentoring new PCs and Associate PCs • Support site regulatory binder setup, start-up activities, site contracts, budgets, regulatory documents, and EC/IRB submissions • Maintain finance, screening, vendor, and overall project trackers • Support vendor coordination, work-scope changes, monthly reporting, revenue recognition, and budget preparation
• University/college degree, preferably in a healthcare/scientific field • Specific clinical research experience may be substituted for education • Relevant and equivalent experience may be accepted in lieu of educational requirements • Fluent in English, both written and verbal • Minimum 2–3 years of experience in a research environment • Minimum 1–2 years of experience working in a project management environment • Knowledge of the clinical trial process; early clinical pharmacology experience preferred • Knowledge of protocol designs, study objectives, study procedures, and project-related timelines • Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines
Apply Now🕒 August 6
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