CRA II: Remote & On-Site Monitoring Specialist

ThermoFisher Scientific; México; A distancia; MXN 1.016.000 - 1.317.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to join our global monitoring team. You will perform remote or on-site visits to assess protocol adherence, regulatory compliance, and manage essential trial documentation, ensuring subject safety and data integrity.

You will monitor sites using risk-based approaches, coordinate investigator meetings, initiate sites, and maintain audit-ready documentation in line with ICH-GCP and sponsor SOPs, while collaborating with

Formación

• Bachelor's degree in life sciences or RN certification.
• 1 year clinical monitoring experience or completion of PPD Drug Development Fellowship.
• Valid driver's license where applicable.

Responsabilidades

• Monitor sites using a risk-based monitoring approach with RCA, SDV/SDR review and site communications.
• Participate in investigator meetings and initiate qualified investigative sites.
• Ensure essential documents are complete per ICH-GCP and applicable regulations.
• Provide trial status updates to the Clinical Team Manager and maintain study systems per conventions.
• Communicate effectively with investigative sites, client and project team across stakeholders.

Conocimientos

Clinical monitoring

ICH GCP

Regulatory compliance

Data management

Communication skills

Educación

Bachelor's degree in life sciences

Registered Nursing certification

Herramientas

Microsoft Office

Descripción del empleo

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to join our global monitoring team. You will perform remote or on-site visits to assess protocol adherence, regulatory compliance, and manage essential trial documentation, ensuring subject safety and data integrity.

You will monitor sites using risk-based approaches, coordinate investigator meetings, initiate sites, and maintain audit-ready documentation in line with ICH-GCP and sponsor SOPs, while collaborating with