Senior Clinical Site Start-Up Specialist

FTARG Fortrea Argentina S.A.; Buenos Aires; A distancia; ARS 1.200.000 - 1.800.000; Jornada completa

Descripción de la vacante

Fortrea Argentina S.A. is seeking a Site Navigator II to coordinate site-level activities during the start-up phase of a clinical study.

You will act as the single point of contact for investigative sites, ensuring regulatory compliance, training, and effective collaboration among sponsor, CRO, and site staff. Responsibilities include overseeing site activation, feasibility assessments, IRB/IEC submissions, and TMF readiness while supporting SIVs and contract/budget negotiations.

Formación

• Minimum 2+ years in clinical development or start-up/regulatory process.
• Strong working knowledge of ICH/GCP and IRB/IEC regulations.
• Ability to communicate and educate stakeholders.

Responsabilidades

• Oversee site activation tasks per ICH/GCP, local regs and SOPs.
• Coordinate with project leadership and local monitors to achieve milestones.
• Identify potential sites and perform feasibility assessments and engagement.
• Support IRB/IEC submissions and renewals.
• Assist in SIV preparation and distribution of study materials.
• Maintain TMF and ensure audit readiness.

Conocimientos

Clinical research knowledge

Regulatory awareness

Communication skills

English language

Educación

Life science degree

Allied health certification

High School Diploma + 5 years experience

Descripción del empleo

Fortrea Argentina S.A. is seeking a Site Navigator II to coordinate site-level activities during the start-up phase of a clinical study.

You will act as the single point of contact for investigative sites, ensuring regulatory compliance, training, and effective collaboration among sponsor, CRO, and site staff. Responsibilities include overseeing site activation, feasibility assessments, IRB/IEC submissions, and TMF readiness while supporting SIVs and contract/budget negotiations.