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    LE

    Leica Biosystems Imaging, Inc.

    Biotechnology

    Clinical Research Associate

    USA - Remote, United StatesFull-time2+ yrs experience$75k – $95kPosted 1w ago
    All Leica Biosystems Imaging, Inc. jobs

    Job description

    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:

    • 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.

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

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

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

    • 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:

    • 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

    • Proven knowledge of regulatory requirements and Good Clinical Practice

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

    • Strong technical background with ability to utilize current and emerging technologies  

    • Ability to work on multiple projects simultaneously

    Travel Requirements:

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

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

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

    • CLSI guidelines and Good Laboratory Practice (GLP)

    • Neurological Disease Research

    Within Danaher Diagnostics, we offer 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 Danaher Benefits Info.

    Within Danaher Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.

    The annual salary range OR the hourly range for this role is $75K-$95K. 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. 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.

    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.

    Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

    The U.S. EEO posters are available here.

    For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here.

    We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [email protected].

    Job details are sourced from the employer's original posting.

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    About the company

    Leica Biosystems Imaging, Inc.

    Leica Biosystems Imaging, Inc. is a global leader in anatomical pathology, providing innovative solutions for cancer diagnosis and research.

    View all Leica Biosystems Imaging, Inc. jobs
    Industry
    Biotechnology
    Open roles
    17

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