Site Activation & Startup Coordinator (Remote)

Fortrea; United States; Remote; USD 65,000 - 105,000; Full time

Job summary

Fortrea is seeking a Site Navigator to coordinate start-up activities for clinical studies across sites in the United States. You will act as the single contact for investigative sites and ensure compliance with regulatory requirements, SOPs and project timelines.

Responsibilities include site identification, feasibility assessment, initial outreach, and TMF management, with collaboration across sponsor, CRO and site staff. Requires ICH/GCP knowledge and strong communication skills.

Qualifications

• Requires strong communication with site staff, CROs and regulators.
• Fluent in English; local language proficiency as applicable.
• Solid understanding of ICH/GCP guidelines and RA/IRB/IEC regulations.
• Experience with investigator start-up documents, contracts and budgets is preferred.

Responsibilities

• Oversee site activation tasks per ICH/GCP and SOPs.
• Identify potential research sites and assess capabilities.
• Conduct initial site outreach and feasibility collection.
• Apply independent judgment to manage site activities and timelines.
• Coordinate remote pre-study visits and follow-up documentation.
• Support translation of informed consent forms and patient materials.
• Collect and review essential documents for TMF readiness and compliance.
• Participate in study team meetings to manage site-level risks.
• Assist CRA team for SIV preparation and study supply distribution.
• Liaise with IRB/IEC and regulatory authorities; assist GRSL as needed.
• Negotiate contracts and budgets with sites.
• Ensure audit readiness and timely, accurate documentation.

Skills

Effective communication

English fluency

Regulatory knowledge

ICH/GCP knowledge

Education

University/College degree (life science)

High School Diploma + 5 years clinical research

Nursing certification / medical or lab tech

Job description

Fortrea is seeking a Site Navigator to coordinate start-up activities for clinical studies across sites in the United States. You will act as the single contact for investigative sites and ensure compliance with regulatory requirements, SOPs and project timelines.

Responsibilities include site identification, feasibility assessment, initial outreach, and TMF management, with collaboration across sponsor, CRO and site staff. Requires ICH/GCP knowledge and strong communication skills.