# Site Navigators II **Company**: Fortrea **Work arrangement**: remote **Experience**: senior **Job type**: full-time **Category**: Healthcare **Industry**: Healthcare **Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Taipei/FSP-SSU--Taipei-_265823?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply **Canonical**: https://yubhub.co/jobs/job_a7fcaae6-404 ## Description Site Navigators II plays 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 Site Navigator II role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff. **Responsibilities:** - 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 - 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 - Actively participate in team meetings to facilitate study progress and implement action plans for site level risks - Support the CRA team in preparing for site initiation visits (SIVs) - Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies (if applicable), 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 - Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines - Ensure Fortrea is audit ready by completing accurate, timely, and consistent system compliance on an ongoing basis - Serve as primary contact for investigative sites and ensure timely delivery in alignment with scope of work/study budget - Perform Case Report Form (CRF) review and data validation against source documentation - Perform country and site ICF review/customization, per local requirements **Qualifications:** - University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution - 3+ years' work experience in clinical research, including a strong working knowledge of the ICH/GCP guidelines and RA, IRB/IEC regulations - Fluent in local official language and in English, both written and verbal **Experience:** - A scientific degree and/ or clinical expertise is optimal for this role - Minimum of 2 +year of experience in clinical development or start-up/ regulatory process - Working knowledge of ICH/GCP, RA, IRB/IEC, and other applicable regulations/guidelines - 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 - 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 **Physical Demands / Work Environment:** - Remote-based work required with possible office presence depending on location - Travel requirements: Limited for training only ## Skills ### Required - ICH/GCP guidelines - RA - IRB/IEC regulations - clinical research - site management - regulatory compliance ### Nice to have - scientific degree - clinical expertise - contract and budget negotiations --- Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Taipei/FSP-SSU--Taipei-_265823?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)