Site Navigator II

🔥 7 minutes ago

🌐 Mexico, Brazil – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✨ Navigator

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 21 days.
• No salary listed.

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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 site-level activities throughout clinical study start-up and potentially closeout • Serve as the single point of contact for investigative sites from feasibility and initial outreach through site activation and maintenance • Ensure regulatory compliance, site management, site support and training, and collaboration among sponsor, CRO, and clinical site staff • Identify and assess potential research sites • Conduct initial site outreach, collect Confidentiality Agreements, and complete feasibility surveys • Conduct remote Pre-Study Visits and complete follow-up documentation • Support customization and translation of informed consent forms and patient-facing materials • Collect, track, and quality-review essential documents for site activation and ongoing regulatory compliance • Support IRB/IEC annual renewals, PI change-over, and document expiration management • Participate in team meetings, implement action plans, and escalate site-level risks and issues • Support CRA teams with site initiation visit preparation, vendor coordination, supplies, access, and document distribution • Submit to and liaise with IRB/IEC, Third Bodies, and Regulatory Authorities • Perform initial and amended contract and budget negotiations with sites • Maintain compliant filing systems and keep the Trial Master File audit ready • Track start-up progress and site requirements/deadlines • Ensure Fortrea remains audit ready through accurate system compliance • Serve as primary investigative-site contact and ensure timely delivery within scope and budget • Perform CRF review, source-data validation, protocol-deviation monitoring, and SAE reporting as applicable • Perform country and site informed-consent-form review and customization • Mentor and train junior colleagues when appropriate

🎯 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 • Fortrea may consider relevant and equivalent experience in lieu of educational requirements • High School Diploma or equivalent AND a minimum of 5 years' work experience in clinical research may be considered in lieu of the above requirement • Strong working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations • Fluent in local official language and in English, both written and verbal • Minimum of 2+ years of experience in clinical development or start-up/regulatory process • Working knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines • Familiarity with investigator start-up documents and contract/budget negotiation process • Previous interaction with operational project teams and investigative sites • Demonstrated understanding of research protocol requirements and ability to communicate and educate others about them • Effective communication with site staff, CRO personnel, and regulatory authorities • Ability to manage multiple tasks and deadlines simultaneously • Ability to identify and resolve potential issues during the start-up process • Ability to negotiate contracts and budgets effectively with research sites

🏖️ Benefits

• Remote-based work • Limited travel for training only • Possible office presence depending on location

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