At Danaher Diagnostics, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Danaher Diagnostics is a community of six companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
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The Clinical Research Associate is responsible for set-up, initiation, execution, monitoring and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories.
This position reports to the Manager, Clinical Site Operations and is part of the Clinical Center of Excellence within Danaher Diagnostics. At Danaher Diagnostics, our vision is to be the leading provider of seamlessly connected diagnostic solutions. The position will be fully remote within the United States.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor’s degree with 2+ years clinical research experience OR Master’s degree with 1+ years clinical research experience
• Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
• Good technical background to understand and communicate current and new technologies
• Ability to work on multiple projects simultaneously

TRAVEL REQUIREMENTS:

• Ability to travel 20%– including overnights, within the US. Travel may be up to 50% during project initiation periods

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Retrospective/prospective biological sample/tissue procurement
• Laboratory experience, especially as a Histotechnician
• Experience with electronic Trial Master Files
  Danaher Diagnostics, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
  The salary range for this role is $80,000- 100,000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range. This range may be modified in the future.
  This job is also eligible for bonus/incentive pay.
  We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
  Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
  

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Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.

• Oversee clinical study protocol execution at external sites, from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP)
• Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data integrity and adherence to project requirements
• Conduct study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events
• Manage IRB submissions and all study regulatory documentation
• Contribute to study planning including budget and timeline forecasts, site identification and qualifications, and process improvement initiatives within the Clinical Center of Excellence