Senior Clinical Monitor Site Oversight and Data Integrity

FTARG Fortrea Argentina S.A.; Buenos Aires; Sur place; ARS 1 000 000 - 1 800 000; Plein temps

Avantages offerts par ce poste

60% travel

On-site role

Résumé du poste

Fortrea Argentina S.A. in Buenos Aires seeks a Senior Clinical Research Associate to manage site monitoring for multiple clinical studies, ensuring ICH GCP compliance, informed consent, protocol adherence, and data integrity across sponsored trials.

This role requires 60% travel to sites, collaboration with investigators, preparation of monitoring plans, and interface with eClinical systems; a degree in a health field and 2+ years of monitoring experience are required, with English proficiency.

Qualifications

• University degree or nursing licensure in a related health field.
• Strong knowledge of ICH GCP and regulatory requirements.
• Experience in clinical monitoring and site management.

Responsabilités

• Manage monitoring visits from pre-study to close-out.
• Verify informed consent and protocol adherence.
• Review source documents and ensure data integrity.
• Maintain site regulatory documents and eTMF.
• Track IP inventory and site supplies.
• Prepare monitoring plans and trip reports.
• Travel as required and participate in investigator meetings.
• Train new staff and mentor junior CRAs.

Connaissances

English fluency

Monitoring procedures

ICH GCP knowledge

Regulatory compliance

Formation

Nursing licensure

Health-related degree

Outils

CTMS

eClinical systems

Source data verification

Description du poste

Fortrea Argentina S.A. in Buenos Aires seeks a Senior Clinical Research Associate to manage site monitoring for multiple clinical studies, ensuring ICH GCP compliance, informed consent, protocol adherence, and data integrity across sponsored trials.

This role requires 60% travel to sites, collaboration with investigators, preparation of monitoring plans, and interface with eClinical systems; a degree in a health field and 2+ years of monitoring experience are required, with English proficiency.