Lead CRA: Clinical Monitoring & Site Oversight

Fortrea; Santiago; In loco; CLP 39.293.000 - 68.762.000; Tempo pieno

Descrizione del lavoro

Fortrea is seeking an experienced Clinical Monitoring professional to lead site management for our clinical studies in Chile. You will ensure subject protection, uphold protocol requirements, and perform comprehensive site monitoring from initiation through close-out, aligning with Fortrea SOPs, ICH GCP, and sponsor expectations.

In this role, you will prepare monitoring plans, manage data integrity, and oversee trial management tools.

Competenze

• Thorough understanding of ICH GCP Guidelines and local regulatory requirements.
• Fluent in English; local language required.
• Experience with clinical monitoring procedures and site management.

Mansioni

• Site management for clinical studies per SOPs and ICH GCP guidelines.
• Perform site monitoring activities including Pre-study, Site Initiation, Process Monitoring, Routine Monitoring and Close-out Visits.
• Prepare and implement project plans related to monitoring responsibilities.
• Protect subjects by ensuring informed consent and protocol adherence.

Conoscenze

ICH GCP knowledge

English language

Clinical monitoring

Regulatory compliance

Attention to detail

Formazione

University degree or allied health certification

Strumenti

eClinical systems

CTMS

Descrizione del lavoro

Fortrea is seeking an experienced Clinical Monitoring professional to lead site management for our clinical studies in Chile. You will ensure subject protection, uphold protocol requirements, and perform comprehensive site monitoring from initiation through close-out, aligning with Fortrea SOPs, ICH GCP, and sponsor expectations.

In this role, you will prepare monitoring plans, manage data integrity, and oversee trial management tools.