Remote Clinical Research Associate | Diagnostics Trials

MedDeviceJobs; Austin (TX); Remote; USD 85,000 - 95,000; Full time

Benefits offered by this job

401(k)

Health insurance

Paid time off

Remote work

Job summary

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to manage IVD and medical device trials at external sites and laboratories. The role is fully remote within the United States, reporting to the Manager, Clinical Site Operations and part of the Global Clinical Affairs organization.

You will solve problems with technical judgement, support regulatory submissions, and collaborate across functions to ensure high-quality data and compliant study conduct.

Qualifications

• Bachelor’s degree with 2+ years clinical research experience OR Master’s degree with 0-2 years clinical research experience
• Regulatory requirements and Good Clinical Practice knowledge for in vitro diagnostic and medical device products
• Experience managing clinical research sites and monitoring study data
• Technical background to understand current and new technologies
• Ability to work on multiple projects simultaneously

Responsibilities

• Oversee site initiation and monitoring from start-up to close-out
• Coordinate with investigators, vendors and internal stakeholders for trial execution
• Assess protocol deviations and adverse events and ensure data integrity
• Manage IRB submissions and regulatory documentation
• Contribute to planning including budgets, timelines and clinical templates

Skills

Clinical research experience

Regulatory knowledge

IRB coordination

Data analysis

Multi-project management

Education

Bachelor’s degree with 2+ years clinical research experience OR Master’s degree with 0-2 years clinical research experience

Tools

Electronic Trial Master Files (eTMF)

Clinical Trial Management Systems (CTMS)

Job description

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to manage IVD and medical device trials at external sites and laboratories. The role is fully remote within the United States, reporting to the Manager, Clinical Site Operations and part of the Global Clinical Affairs organization.

You will solve problems with technical judgement, support regulatory submissions, and collaborate across functions to ensure high-quality data and compliant study conduct.