Clinical Research Associate (CRA)

Radiometer; United States; Teletrabalho; USD 85 000 - 95 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

401(k) plan

Paid time off

Remote work options

Resumo da oferta

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to lead setup, initiation, monitoring, and close-out of IVD and medical device trials at external sites within the United States. This is a fully remote role with broad exposure to the Global Clinical Affairs organization.

You will oversee protocol execution, build relationships with investigators and vendors, monitor studies, and manage regulatory submissions while contributing to budgeting and planning efforts.

Qualificações

• Bachelor’s degree or Master’s with clinical research experience.
• Knowledge of regulatory requirements and GCP for in vitro diagnostic and medical device products.
• Experience with managing clinical research sites and monitoring data.

Responsabilidades

• Oversee protocol execution at external sites from start-up to close-out.
• Develop relationships with investigators, stakeholders and vendors for trial success.
• Conduct study monitoring, including site coordination and safety assessments.
• Manage IRB submissions and regulatory documents.
• Contribute to study planning, budgets, timelines and process improvements.

Conhecimentos

Clinical research

Regulatory knowledge

FDA GCP

Multi-project management

Technical communication

Formação académica

Bachelor’s degree

Master’s degree

Ferramentas

Electronic Trial Master Files (eTMF)

Clinical Trial Management Systems (CTMS)

Regulatory documentation tools

Descrição da oferta de emprego

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.

About the Role

The Clinical Research Associate (CRA) 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. The CRA should be able to solve problems and analyze possible solutions using technical experience and judgement, while receiving a moderate level of guidance and direction. 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:

• 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; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc.

Essential Requirements

• 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
• Previous experience with managing clinical research sites and monitoring clinical study data
• Good technical background to understand and communicate current and new technologies
• Ability to work on multiple projects simultaneously
• Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel 20-70%, including overnight(s), within the US. Travel may be up to 70% during project initiation periods

Preferred Experience

• Retrospective/prospective biological sample procurement
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• Demonstrated understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision/reproducibility, reference interval, specimen stability, clinical performance, and point-of-care evaluations.

Additional Information

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.

Compensation

The annual salary range OR the hourly range for this role is $85,000 - $95,000. 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. 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.

Equal Opportunity

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.

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, we provide the necessary support.

About Danaher

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. For more information, visit www.danaher.com.