Clinical Research Associate I - Risk-Based Monitoring

ThermoFisher Scientific; Argentina; A distancia; ARS 800.000 - 1.600.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Clinical Monitoring Specialist to coordinate site visits and ensure protocol and regulatory compliance across sponsors and monitoring environments. You will conduct remote or on-site visits, manage trial documentation, and ensure data reliability in accordance with ICH-GCP and SOPs.

The role emphasizes risk-based monitoring, SDR/SDV/CRF reviews, site performance assessment, and timely reporting.

Formación

• Bachelor's degree in life sciences or RN certification.
• Minimum clinical monitoring experience equivalent to 2 years in clinical trials.
• Knowledge of ICH-GCP and applicable regulations.

Responsabilidades

• Monitor investigator sites using a risk-based approach.
• Perform SDR, SDV and CRF review to ensure data accuracy.
• Document observations and escalate issues with timely reporting.
• Coordinate investigator visits and close-out activities.

Conocimientos

Risk-based monitoring

Root cause analysis

CRA monitoring

ICH GCP knowledge

Communication skills

Microsoft Office

Educación

Bachelor's degree in life sciences

Registered Nursing certification

Herramientas

CTMS

Descripción del empleo

Thermo Fisher Scientific is seeking a Clinical Monitoring Specialist to coordinate site visits and ensure protocol and regulatory compliance across sponsors and monitoring environments. You will conduct remote or on-site visits, manage trial documentation, and ensure data reliability in accordance with ICH-GCP and SOPs.

The role emphasizes risk-based monitoring, SDR/SDV/CRF reviews, site performance assessment, and timely reporting.