Remote Clinical Start-Up Navigator II (Taipei)

Fortrea; United States; Remote; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Fortrea in United States seeks a Site Navigators II to coordinate site-level start-up activities for clinical studies, serving as the primary contact for investigative sites while ensuring regulatory compliance per ICH/GCP and local requirements.

You will identify potential sites, conduct outreach, manage essential documents, support IRB processes, prep for site initiation visits, and negotiate contracts/budgets, mentoring junior colleagues as appropriate.

Qualifikationen

• University/College degree (life science preferred) or related allied health degree or 3+ years in clinical research with ICH/GCP knowledge.
• Fluent in local language and English, both written and verbal.

Aufgaben

• Oversee site activation tasks per ICH/GCP, local regulations, SOPs and project needs.
• Identify potential research sites and assess capabilities and resources.
• Conduct site outreach, engagement, confidentiality agreements, and feasibility surveys.
• Coordinate remote pre-study visits and follow-up documentation for site selection.
• Support translation/customization of informed consent forms and patient materials.
• Maintain site regulatory documents, renewals, PI changes, and expirations per local requirements.
• Participate in team meetings and escalate issues affecting milestones.
• Assist CRA team for site initiation visits and distribution of study materials.
• Liaise with IRB/IEC and Regulatory Authorities with GRSL collaboration.
• Negotiate contracts and budgets with sites; ensure TMF is audit-ready.

Kenntnisse

ICH/GCP

RA/IRB/IEC regulations

Site start-up

Contract/budget negotiation

Stakeholder communication

Ausbildung

University/College degree (life sciences preferred)

3+ years clinical research experience

Tools

None

Jobbeschreibung

Fortrea in United States seeks a Site Navigators II to coordinate site-level start-up activities for clinical studies, serving as the primary contact for investigative sites while ensuring regulatory compliance per ICH/GCP and local requirements.

You will identify potential sites, conduct outreach, manage essential documents, support IRB processes, prep for site initiation visits, and negotiate contracts/budgets, mentoring junior colleagues as appropriate.