Senior CRA – Cell Therapy Monitoring & Study Leadership

ThermoFisher Scientific; España; A distancia; EUR 42.000 - 62.000; Jornada completa

Descripción de la vacante

Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (Level I) to monitor clinical sites in a risk-based approach. You will ensure data integrity through SDR/SDV and CRF reviews, manage site visits on-site or remotely, and maintain compliant trial conduct per ICH-GCP.

Strong communication, problem solving, and collaboration with global teams are essential. This role requires 3+ years as CRA, 2+ years in cell therapy, and willingness to work across multiple locations.

Formación

• Total experience: at least 3 years as a CRA.
• Cell therapy experience: at least 2 years on-site.
• Location: various locations.

Responsabilidades

• Monitor investigator sites using risk-based monitoring and perform RCA to identify process failures and CAPAs.
• Provide trial status updates to the Clinical Team Manager and ensure CTMS data is current.
• Participate in investigator meetings and initiate sites per protocol while ensuring regulatory compliance.
• Verify essential documents per ICH-GCP and conduct on-site file reviews as required.
• Assist in publication tooling and share insights with the project team to improve processes.
• Facilitate communication between sites, client and project team and support audits/inspections.

Conocimientos

Risk-based monitoring

Root cause analysis

SDR/SDV/CRF review

Regulatory compliance

CTMS familiarity

Communication skills

Herramientas

CTMS

Microsoft Office

Descripción del empleo

Thermo Fisher Scientific is seeking a Senior Clinical Research Associate (Level I) to monitor clinical sites in a risk-based approach. You will ensure data integrity through SDR/SDV and CRF reviews, manage site visits on-site or remotely, and maintain compliant trial conduct per ICH-GCP.

Strong communication, problem solving, and collaboration with global teams are essential. This role requires 3+ years as CRA, 2+ years in cell therapy, and willingness to work across multiple locations.