Senior CRA II – Denmark | ICH-GCP & Site Oversight Expert

ThermoFisher Scientific; Denmark; Remote; DKK 600,000 - 900,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to oversee monitoring and site management for multinational trials. You will conduct remote or on-site visits to verify protocol adherence and regulatory compliance, while coordinating documentation across sponsors and monitoring environments.

The role requires a strong background in clinical monitoring, ICH-GCP guidelines, and excellent communication.

Qualifications

• Bachelor’s degree in a life sciences related field or RN certification or equivalent.
• 1 year of clinical research monitor experience or completion of a related fellowship.
• Valid driver’s license where applicable.

Responsibilities

• Monitor investigator sites using a risk-based approach and ensure data accuracy.
• Coordinate and participate in investigator meetings and site initiation.
• Manage essential documents per ICH-GCP and regulations.
• Provide trial status updates to the Clinical Team Manager.
• Maintain communications with investigative sites, client, and project team.
• Support publication and tool development activities for the project.

Skills

CRA experience

CNS/Alzheimer’s

Clinical monitoring

ICH-GCP knowledge

Regulatory knowledge

Data review

Communication skills

Microsoft Office

Clinical trial management system

Education

Bachelor's degree in a life sciences related field

Registered Nursing certification

Equivalent combination of education/experience

Tools

Microsoft Office

Clinical Trial Management System

Job description

Thermo Fisher Scientific is seeking a Clinical Research Associate (Level II) to oversee monitoring and site management for multinational trials. You will conduct remote or on-site visits to verify protocol adherence and regulatory compliance, while coordinating documentation across sponsors and monitoring environments.

The role requires a strong background in clinical monitoring, ICH-GCP guidelines, and excellent communication.