Clinical Research Associate (CRA)

Danaher Corporation; United States; Remoto; USD 85.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Remote work arrangements

Benefits package

Descrizione del lavoro

The Clinical Research Associate (CRA) role at Danaher Diagnostics offers remote work within the United States. You’ll manage set-up, initiation, monitoring and close-out of IVD and medical device trials at external sites, solving problems with technical judgment and guidance.

You will collaborate with clinical sites, investigators, and vendors, ensuring data integrity, regulatory compliance, and timely study milestones, while supporting IRB submissions and study documents.

Competenze

• Bachelor's degree with 2+ years clinical research experience or Master's degree with 0-2 years clinical research experience.
• 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.

Mansioni

• 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.

Formazione

Bachelor's degree + 2+ years clinical research

Master's degree + 0-2 years clinical research

Descrizione del lavoro

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 (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.

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
• 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

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

• 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.

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 $85,000 - $95,000 . Th