Project Coordinator, Clinical Pharmacology

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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

• Coordinate and complete project tasks supporting Project Management for low to medium complex clinical studies, including external site studies • Initiate and maintain study-specific documents and plans, including Project Management Plans, Communication Plans, Risk Mitigation Plans, Investigator Package Plans, and training matrices • Develop and maintain trial management tools, project timelines, CTMS, project trackers, risk registers, contact lists, and filing structures • Organize and attend study-related meetings, distribute agendas and minutes, monitor follow-up actions, and lead external site calls • Coordinate document transfer and quality control within the Trial Master File and routinely post documents to internal SharePoint or client websites • Support project setup, timeline updates, sponsor and internal training, regulatory binders, and start-up activities • Serve as sponsor and external site contact during study maintenance and respond to site queries • Manage payment processes, finance tracking, budgeted hours, revenue recognition timelines, monthly reporting, and budgets • Liaise with vendors and internal Fortrea functions to support projects and maintain tracking documents • Assist with training and mentoring new Project Coordinators and Associate Project Coordinators

🎯 Requirements

• University/college degree, preferably in a healthcare or 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 • Knowledge of the clinical trial process; early clinical pharmacology experience preferred • Minimum 2–3 years of experience in a research environment • Minimum 1–2 years of experience working in a project management environment • Knowledge of protocol designs, study objectives, study procedures, and project-related timelines • Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines