Senior Site Navigator

🔥 3 minutes ago

🌐 Mexico, Brazil – Remote

🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

✨ Navigator

👻 Ghost score 10%

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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 • Act as local country expert in study start-up activities • Mentor and train junior colleagues when suitable • Identify and assess potential research sites and their capabilities • Conduct initial site outreach, confidentiality agreement collection, and 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 site activation documents • Maintain site regulatory compliance, including annual IRB/IEC renewals, PI changes, and document expirations • Participate in study team meetings and develop action plans for site risks, underperforming sites, and milestone-impacting 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 • File high-quality documents in applicable systems and keep the Trial Master File audit ready • Track start-up progress and ensure sites meet requirements and deadlines • Maintain accurate system compliance and audit readiness • Serve as primary site contact 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 ICF review and customization • Perform other assigned duties

🎯 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 3-5 years' work experience in clinical research • Relevant and equivalent experience may be considered 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 3+ years of experience in clinical development or start-up/regulatory process • Thorough 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 • Understanding of research protocol requirements and ability to communicate and educate others about them • Ability to manage multiple tasks and deadlines simultaneously • Understanding of relevant clinical trial and research regulations and guidelines • Ability to identify and resolve potential start-up process issues • 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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