Fortrea
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.
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Fortrea
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 site-level activities throughout clinical study start-up and potentially closeout • Serve as the primary point of contact for investigative sites • Identify and assess potential research sites • Conduct initial site outreach and collect confidentiality agreements and feasibility surveys • Manage remote pre-study visits and follow-up documentation • Support customization and translation of informed consent forms and patient-facing materials • Collect, track, and quality-review essential documents required for site activation • Maintain site regulatory compliance and support IRB/IEC renewals, PI changes, and document expirations • Participate in study team meetings and develop action plans for site-level risks and issues • Support CRA teams with site initiation visit preparation and coordination of supplies, access, and documents • Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities • Conduct initial and amended contract and budget negotiations with research sites • Maintain audit-ready filing systems and update the Trial Master File • Track start-up progress and ensure sites meet requirements and deadlines • Serve as primary contact for investigative sites and ensure timely delivery within scope and budget • Perform CRF review and source-data validation, and monitor protocol deviations and SAE reporting • Perform country and site informed-consent-form review and customization • Complete other assigned duties throughout the study
🎯 Requirements
• University/College degree in a relevant field, life science preferred, or certification in a related allied health profession • Alternatively, 2–3 years of clinical research work experience may substitute for educational requirements • Alternatively, a High School Diploma or equivalent and at least 5 years of clinical research experience • At least 1 year of experience in a related field • One year of clinical research experience preferred • Working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations • Familiarity with investigator start-up documents and contract/budget negotiation processes • Understanding of research protocol requirements • Fluent in the local official language and English, written and verbal • Ability to manage multiple tasks and deadlines • Ability to identify and resolve start-up issues • Ability to negotiate contracts and budgets with research sites • Ability to use in-house and off-the-shelf computer software • Ability to sit for extended periods and operate a vehicle safely • Regular and consistent attendance; varied hours may be required
🏖️ Benefits
• Remote-based work • Travel limited to training only • EEO & accommodations support • Global Talent Network opportunities • Career opportunities contributing to life-saving therapies • Teamwork and excellence-focused work environment
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