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Site Navigator I

Role overview

Qualifications

  • University degree (life sciences preferred)
  • Minimum 1 year experience in Clinical Operations or Start-Up
  • Knowledge of ICH/GCP and clinical trial processes
  • Strong organizational skills, attention to detail, effective communication and willingness to learn

Responsibilities

  • Perform site identification, feasibility, and start-up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
  • Coordinate and track essential regulatory documents to ensure timely and compliant site activation
  • Act as a primary point of contact for investigative sites during the start-up and possibly the maintenance phase
  • Perform ethics committee and regulatory authority submissions, renewals, and prepare the relevant regulatory documentation in collaboration with internal teams

Key facts

Other skills

  • Organizational Skills
  • Detail Oriented
  • Communication

About the company

Fortrea logo

Fortrea

Contract Research Organizations (CRO)

We are creative thinkers with decades of clinical trial experience who drive innovative solutions powered by insights from data and technology. As we tackle challenges in today’s world, we know that we need to be nimble and agile. That’s why we work side-by-side with our partners to eliminate inefficiencies from the process so we can help them deliver life-changing therapies faster for patients, caregivers and healthcare providers worldwide.

Company details

Company typeXLarge
IndustryContract Research Organizations (CRO)
Company size10001

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Job description

Site Navigator I

Location: remote
 

We are looking for a clinical operations professional to join our team as Site Navigator I, managing clinical trial start‑up activities with additional in‑house CRA responsibilities. This is an excellent, comprehensive role for someone looking to grow their career in clinical research within a global CRO environment.

Key Responsibilities

  • Perform site identification, feasibility, and start‑up activities, including site outreach, feasibility questionnaires, and confidentiality agreements
  • Coordinate and track essential regulatory documents to ensure timely and compliant site activation
  • Act as a primary point of contact for investigative sites during the start‑up and possibly the maintenance phase
  • Perform ethics committee and regulatory authority submissions, renewals, and prepare the relevant regulatory documentation in collaboration with internal teams
  • Perform site contract and budget negotiations under guidance
  • Perform remote Pre-Study Visits
  • Support Site Initiation Visit (SIV) preparation, including coordination of documents, systems access, and study supplies
  • Perform remote/in‑house CRA activities, such as document review, CRF review, data validation, and remote monitoring tasks (after required training)
  • Maintain accurate documentation in study systems and ensure the TMF is inspection‑ready
  • Collaborate closely with CRAs, project teams, and study stakeholders to support study milestones

Qualifications

  • University degree (life sciences preferred)
  • Minimum 1 year experience in Clinical Operations or Start-Up
  • Knowledge of ICH/GCP and clinical trial processes
  • Strong organizational skills, attention to detail, effective communication and willingness to learn
  • Ability to manage multiple tasks in a structured and proactive way

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MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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