Senior Site Navigator

DevOps EngineerDevOps EngineerFull TimeRemoteSeniorTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

Worldwide

Posted

51 days ago

Salary

0

Seniority

Senior

No structured requirement data.

Job Description

Senior Site Navigator

Fortrea

Role Description Senior Site Navigators play a critical role in the comprehensive coordination of site-level activities throughout the start-up phase of a clinical study and potentially through closeout activities as required. Serving as the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation, extending through the maintenance phase of the study as required. A crucial component in meeting the requirements of the Senior Site Navigator role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. The Senior Site Navigator serves as local country expert in study start-up activities for a particular country or region. As senior team members, they perform work with limited oversight and their responsibilities include acting as a “knowledge resource,” mentoring/training junior colleagues if suitable. The Senior Site Navigator proactively anticipates and mitigates issues that could delay the study. 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 3-5 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. Requirements - A scientific degree and/or clinical expertise is optimal for this role. - 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/budgets negotiation process; previous interaction with operational project teams and investigative sites. - Demonstrated understanding of research protocol requirements and proven ability to communicate them/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. Benefits - Remote-based work required with possible office presence depending on location. - Travel requirements: Limited for training only.

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