Remote CRA for Diagnostics Trials

Radiometer; United States; Remote; USD 85,000 - 95,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Remote work options

Job summary

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to lead setup, initiation, monitoring, and close-out of IVD and medical device trials at external sites within the United States. This is a fully remote role with broad exposure to the Global Clinical Affairs organization.

You will oversee protocol execution, build relationships with investigators and vendors, monitor studies, and manage regulatory submissions while contributing to budgeting and planning efforts.

Qualifications

• Bachelor’s degree or Master’s with clinical research experience.
• Knowledge of regulatory requirements and GCP for in vitro diagnostic and medical device products.
• Experience with managing clinical research sites and monitoring data.

Responsibilities

• Oversee protocol execution at external sites from start-up to close-out.
• Develop relationships with investigators, stakeholders and vendors for trial success.
• Conduct study monitoring, including site coordination and safety assessments.
• Manage IRB submissions and regulatory documents.
• Contribute to study planning, budgets, timelines and process improvements.

Skills

Clinical research

Regulatory knowledge

FDA GCP

Multi-project management

Technical communication

Education

Bachelor’s degree

Master’s degree

Tools

Electronic Trial Master Files (eTMF)

Clinical Trial Management Systems (CTMS)

Regulatory documentation tools

Job description

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to lead setup, initiation, monitoring, and close-out of IVD and medical device trials at external sites within the United States. This is a fully remote role with broad exposure to the Global Clinical Affairs organization.

You will oversee protocol execution, build relationships with investigators and vendors, monitor studies, and manage regulatory submissions while contributing to budgeting and planning efforts.