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Fortrea5 days ago

Site Navigator I

Remote · Buenos Aires, Buenos Aires F.D., Argentina

Type
Full Time
Level
Mid Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Site Navigator I overseeing start-up and activation of clinical study sites, ensuring regulatory compliance, site management, and collaboration between sponsor, CRO, and site staff. Responsibilities include site activation, feasibility assessment, outreach and feasibility surveys, document collection and quality review, IRB/IEC coordination, translation/customization of informed consent and patient materials, SIV preparation, contract and budget negotiations, TMF maintenance, ongoing regulatory compliance, and inter-team coordination to meet milestones. Requires ICH/GCP knowledge, ability to coordinate with sites and regulators, and strong written/verbal communication in local language and English.

Required Qualifications

  • University/College degree (life science preferred) or certification in allied health
  • 2-3 years' work experience in clinical research with knowledge of ICH/GCP, RA, IRB/IEC regulations
  • Fluent in local official language and in English (written and verbal)
  • Experience: at least 1 year in related field; clinical research preferred
  • Ability to manage multiple tasks and deadlines; strong communication with stakeholders
  • Knowledge of investigator start-up documents and contract/budgets negotiation
  • Understanding of regulatory requirements and trial management
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Site Navigator I

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