Clinical Research Associate

Lensa; Boston (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

Join a leading company in life sciences as a Clinical Research Associate. This fully remote position focuses on monitoring and overseeing clinical trials, ensuring compliance with FDA standards, while contributing to meaningful advancements in cancer diagnostics. With an emphasis on collaboration and continuous improvement, you will play a crucial role in gathering timely data that ultimately impacts patient care.

Benefits

Comprehensive health benefits

401(k)

Flexible working arrangements

Paid time off

Qualifications

• 2+ years clinical research experience or 0-2 years with Master's degree.
• Basic knowledge of FDA standards.
• Ability to handle multiple projects simultaneously.

Responsibilities

• Oversee clinical study protocol execution at external sites.
• Manage IRB submissions and all study regulatory documentation.
• Conduct study monitoring and ensure compliance.

Skills

Regulatory requirements

Good Clinical Practice

Technical understanding

Multi-project management

Education

Bachelor’s degree

Master’s degree

Job description

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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?

At Leica Biosystems, one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work 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.

At Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

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 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

• 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 Global Clinical Affairs organization
  
  

The Essential Requirements Of The Job Include

• Bachelor’s degree with 2+ years clinical research experience OR Master’s degree with 0-2 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 30%– 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 procurement
• Laboratory experience, especially as a Histotechnician
• Experience with electronic Trial Master Files
  
  

A Leica Biosystems, a Danaher operating 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 Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

At Leica Biosystems, 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 for Leica Biosystems can provide.

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.

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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [e-mail] to request accommodation.

If you have questions about this posting, please contact [e-mail]

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  IT Services and IT Consulting

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