Clinical Research Associate

🏢 Danaher · all 489 jobs
📍 USA - Deer Park - Leica Biosystems
📅 Posted Posted Yes · via Workday
🏷 Remote
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Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?  

Within Danaher the work our diagnostic businesses do saves lives—and we’re all united by a shared commitment to innovate for tangible impact.   

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. 

We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies we are driving innovation through partnerships with top academic institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding access to precision diagnostics for millions of people worldwide - and we’re using our unmatched global scale and proven playbook to make it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment options and saving lives.

Learn about the Danaher Business System which makes everything possible.

The Clinical Research Associate II 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 Global Clinical Affairs organization. The position will be fully remote within the United States.   

In this role, you will have the opportunity to:

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Lead clinical study execution across external sites from start-up through close-out, ensuring protocol compliance, timely data collection, issue resolution, and adherence to GCP and regulatory requirements.

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Build and maintain collaborative relationships with investigators, institutions, vendors, and cross-functional stakeholders to support study delivery, data integrity, and project objectives .

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Conduct study monitoring activities, including site oversight, investigational product accountability, and management of protocol deviations and adverse events, driving appropriate corrective and preventive actions.

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Manage IRB/IEC submissions, amendments, and study regulatory documentation, ensuring completeness and compliance with applicable regulations.

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Support study planning and execution through site identification, qualification, activation, contract and budget negotiations, and continuous process improvement initiatives within Global Clinical Affairs.

The essential requirements of the job include:

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Bachelor’s degree (Life Sciences, Healthcare, or a related field preferred) with 3+ years clinical research experience OR Master’s degree in field with 2+ years of related work experience, or demonstrated employment equivalency

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Proven knowledge of regulatory requirements and Good Clinical Practice

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Experience with in vitro diagnostic (IVD) and medical device clinical trials (preferred)

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Strong technical background with ability to utilize current and emerging technologies

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Ability to work on multiple projects simultaneously

Travel Requirements:

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Ability to travel 20 -70 %– including overnights , within the US . Travel may be up to 7 0% during project initiation periods

It would be a plus if you also possess previous experience in:

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Experience with electronic Trial Master Files (eTMF), Electronic Data Capture (EDC) systems, and Clinical Trial Management Systems (CTMS)

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CLSI guidelines and Good Laboratory Practice (GLP)

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Neurological Disease Research

Within Danaher Diagnostics , we offer a broad array of comprehensive, competitive benefit progr

Flights + hotels

This role requires you to be in USA - Deer Park - Leica Biosystems. If that means relocating or flying in, it is worth checking fares before you commit to a start date.

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