Site Navigator II
Remote · Mexico City, Mexico City, Mexico
Job Summary
Site Navigator II oversees start-up activities and regulatory compliance for clinical studies, serving as the primary contact for investigative sites and coordinating feasibility, site activation, and ongoing site management in alignment with ICH/GCP guidelines, local regulations, and sponsor/CRO requirements. Responsibilities include identifying suitable research sites, conducting outreach and feasibility assessments, coordinating site initiation visits, translating and customizing informed consent materials, ensuring regulatory compliance and timely document submission (IRB/IEC, TMF), supporting budget and contract negotiations, and mentoring junior colleagues while collaborating with sponsor, CRO, and site staff to meet milestones and protect patient safety. The role requires strong communication with site staff and regulators, ability to manage multiple tasks, and familiarity with start-up documentation, ICH/GCP, and local regulatory frameworks.
Required Qualifications
- 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, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- 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, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations will be considered.
- 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/budgets negotiation process; previous interaction with operational project teams and investigative sites.
- Demonstrated understanding of research protocol requirements and proven ability to communicate and educate others about them.
- Effective communication with various stakeholders, including site staff, CRO personnel, and regulatory authorities.
- Ability to manage multiple tasks and deadlines simultaneously, ensuring that all requirements are met in a timely manner.
- Understanding of relevant regulations and guidelines related to clinical trials and research.
- Ability to identify and resolve potential issues that may arise during the start-up process.
- Ability to negotiate contracts and budgets effectively with research sites.
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