Remote CRA — Accelerate Life-Saving Diagnostics

Emploive; Austin, Northern (TX, KY); Hybrid; USD 85,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Danaher Diagnostics is seeking a Clinical Research Associate to oversee IVD and medical device clinical trials at external sites. The role is fully remote within the United States and reports to the Manager, Clinical Site Operations within Global Clinical Affairs.

You will monitor sites for protocol execution, data integrity, and regulatory compliance, while coordinating IRB submissions and study documentation across projects. Travel up to 70% may be required during initiation phases.

Qualifications

• Bachelor’s degree in Life Sciences with 2+ years clinical research experience, or Master’s with 0–2 years.
• Knowledge of regulatory requirements and Good Clinical Practice for IVD/medical devices.
• Experience managing clinical research sites and monitoring study data.

Responsibilities

• Oversee external site protocol execution from start-up to close-out, ensuring data collection and FDA/GCP compliance.
• Develop and maintain relationships with institutions, investigators, stakeholders, and vendors.
• Conduct study monitoring including site coordination and assessment of deviations/adverse events.
• Manage IRB submissions and regulatory documentation for studies.
• Contribute to study planning, budgeting, timelines, and process improvements.

Skills

Regulatory knowledge

GCP familiarity

Clinical site management

Monitoring & data integrity

IRB submissions

Budget & timeline planning

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Tools

Electronic TMF

Clinical Trial Management System (CTMS)

Job description

Danaher Diagnostics is seeking a Clinical Research Associate to oversee IVD and medical device clinical trials at external sites. The role is fully remote within the United States and reports to the Manager, Clinical Site Operations within Global Clinical Affairs.

You will monitor sites for protocol execution, data integrity, and regulatory compliance, while coordinating IRB submissions and study documentation across projects. Travel up to 70% may be required during initiation phases.