Lead CRA - Site Monitoring & Trial Oversight

Fortrea; Buenos Aires; On-site; ARS 1,200,000 - 1,800,000; Full time

Job summary

Fortrea is seeking an experienced Clinical Monitoring professional to oversee site visits and data integrity for multiple studies. The role requires strong knowledge of ICH GCP, regulatory compliance, and hands-on CRA experience across monitoring activities.

The position involves coordinating with study teams, preparing monitoring plans, and ensuring subject protection while managing travel to study sites in a dynamic environment.

Qualifications

• Bachelor's degree in a related field or nursing licensure; equivalent experience considered.
• Thorough understanding of ICH GCP guidelines and local regulatory requirements.
• Fluent in English and local language, both written and verbal.
• Strong monitoring procedures knowledge and data integrity focus.

Responsibilities

• Site management and monitoring of clinical studies per SOPs, ICH GCP, and sponsor requirements.
• Lead CRA activities and support project plans for monitoring.
• Prepare monitoring plans, site initiation slides, and trip reports.
• Ensure subject protection, informed consent, and regulatory compliance.
• Maintain data integrity through source data verification and query resolution.
• Monitor IP inventory, site regulatory documents, and eTMF/Sponsor documents.
• Travel as required (up to 60%) to study sites.
• Attend meetings and train staff as needed.

Skills

Clinical monitoring

ICH GCP knowledge

English proficiency

Travel readiness

Education

Bachelor's degree or nursing licensure

Tools

CTMS

eClinical systems

eTMF

Job description

Fortrea is seeking an experienced Clinical Monitoring professional to oversee site visits and data integrity for multiple studies. The role requires strong knowledge of ICH GCP, regulatory compliance, and hands-on CRA experience across monitoring activities.

The position involves coordinating with study teams, preparing monitoring plans, and ensuring subject protection while managing travel to study sites in a dynamic environment.