Fortrea
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.
Site Navigator II – Study Startup Specialist
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Fortrea
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
• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements • Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources • Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey • Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required • Support customization and translation of informed consent forms and patient-facing materials • Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation • Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations • Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones • Support the CRA team in preparing for site initiation visits (SIVs) • Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities • Perform initial contract and budget negotiations with the sites • Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times • Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines • Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations.
🎯 Requirements
• University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) or 3+ years' work experience in clinical research • A strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations • In lieu of the above requirement, candidates with a High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research will be considered • Fluent in local official language and in English, both written and verbal • Advanced experience in start-up/ regulatory process (TGA and Bellberry) • Advanced knowledge of HREC & RGO submissions, ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines • Familiarity with investigator start-up documents and contract/budgets negotiation process • Previous interaction with operational project teams and investigative sites • Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner • Ability to negotiate contracts and budgets effectively with research sites.
🏖️ Benefits
• Remote-based work required with possible office presence depending on location • Limited travel for training only
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