Senior CRA - On-Site/Remote Monitoring

ThermoFisher Scientific; États-Unis; À distance; USD 90 000 - 120 000; Plein temps

Résumé du poste

Thermo Fisher Scientific seeks an experienced Clinical Research Associate (Level II) to monitor investigator sites and manage site qualification, regulatory documents, and trial travel. You will perform on-site and remote visits, ensuring protocol adherence, data integrity, and audit readiness across diverse sponsors and environments.

The role requires strong knowledge of ICH-GCP, regulatory requirements, and excellent communication.

Qualifications

• Bachelor's degree in life sciences or RN certification.
• 2 years' experience in clinical research monitoring.
• Valid driver's license where applicable.

Responsabilités

• Monitor sites using risk-based monitoring and ensure data accuracy through SDR/SDV/CRF reviews.
• Provide trial status updates and CTMS-based reports to the Clinical Team Manager.
• Coordinate investigator meetings and initiate sites per protocol and regulatory requirements.
• Ensure essential documents are complete per ICH-GCP and regulations; conduct on-site file reviews.
• Contribute to project publications/tools and support process improvements.
• Facilitate effective communication between sites, clients, and the project team.

Connaissances

Clinical monitoring

Regulatory knowledge

Documentation

Communication

Risk-based monitoring

Clinical trial coordination

Formation

Bachelor's degree life sciences

RN certification

Outils

CTMS

Microsoft Office

EDC

Description du poste

Thermo Fisher Scientific seeks an experienced Clinical Research Associate (Level II) to monitor investigator sites and manage site qualification, regulatory documents, and trial travel. You will perform on-site and remote visits, ensuring protocol adherence, data integrity, and audit readiness across diverse sponsors and environments.

The role requires strong knowledge of ICH-GCP, regulatory requirements, and excellent communication.