# Site Navigators II

**Company**: Fortrea
**Location**: Remote Mexico
**Work arrangement**: remote
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Mexico/Site-Navigator-II_266608?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_86fdadf1-d1a

## Description

## Job Overview

The Site Navigators II role plays a critical part in coordinating site-level activities during the start-up phase of a clinical study and potentially through closeout activities. As the single point of contact for investigative sites, this role ensures smooth progression from feasibility and initial outreach through to site activation and maintenance phases of the study. A key component of this role is ensuring regulatory compliance, robust site management, optimal site support and training, and effective collaboration between the sponsor, CRO, and clinical site staff.

## Summary of Responsibilities:

- Oversee site-level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs, and project requirements.

- Identify potential research sites that align with the study's criteria and assess their capabilities and resources.

- Conduct initial site outreach, collect Confidentiality Agreements, and feasibility surveys.

- Perform remote Pre-Study Visits and follow-up documentation.

- Support customisation and translation of informed consent forms and patient-facing materials.

- Collect, track, and review essential documents required for effective and compliant study site activation.

- 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.

- Liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities.

- Perform initial contract and budget negotiations with sites.

- Ensure high-quality documents are filed in applicable systems and the Trial Master File is updated and audit-ready.

- Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines.

- Serve as the primary contact for investigative sites and ensure timely delivery in alignment with the scope of work/study budget.

- Perform Case Report Form review and data validation against source documentation.

## Qualifications (Minimum Required):

- University/College degree (life science preferred), or certification in a related allied health profession, or 3+ years' work experience in clinical research.

- Strong working knowledge of ICH/GCP guidelines and RA, IRB/IEC regulations.

- Fluent in local official language and in English, both written and verbal.

## Experience (Minimum Required):

- 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.

- Demonstrated understanding of research protocol requirements and proven ability to communicate and educate others.

- Effective communication with various stakeholders.

- Ability to manage multiple tasks and deadlines simultaneously.

## Physical Demands / Work Environment:

- Remote-based work required with possible office presence depending on location.

- Travel requirements: Limited for training only.

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## 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

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Source: [Apply at fortrea.wd1.myworkdayjobs.com](https://fortrea.wd1.myworkdayjobs.com/en-US/Fortrea/job/Remote-Mexico/Site-Navigator-II_266608?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)