Senior Clinical Research Associate

Radiometer; United States; Remote; USD 103,000 - 130,000; Full time

Benefits offered by this job

Bonus pay

Job summary

Danaher Diagnostics is seeking a Sr. Clinical Research Associate (Sr. CRA) for a fully remote role within the United States.

You will set up, initiate, execute, monitor, and close out IVD and medical device clinical trials at external sites, independently training and managing sites under the Global Clinical Affairs arm. You will oversee protocol execution, maintain relationships with institutions, monitor data quality, manage regulatory submissions, and contribute to study planning and

Qualifications

• Bachelor’s degree with 5+ years clinical research experience OR Master’s degree with 3+ years clinical research experience OR Doctoral degree in field with 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.

Responsibilities

• 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 independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queries.
• Manage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to date and audit ready.
• Contribute to study planning including budget and contract negotiation 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.

Skills

Clinical research

Regulatory knowledge

Multi-project management

Technical communication

Education

Bachelor's degree

Master's degree

Doctoral degree

Tools

Electronic TMF

CTMS

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 Sr. Clinical Research Associate (Sr. 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 Sr. CRA should be able to independently train and manage external clinical research sites. 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 independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queries
• Manage IRB submissions and all study regulatory documentation to ensure Trial Master File is kept up to date and audit ready
• Contribute to study planning including budget and contract negotiation 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 5+ years clinical research experience OR Master’s degree with 3+ years clinical research experience OR Doctoral degree in field with 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 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.

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.

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.

The annual salary range OR the hourly range for this role is $103,000.00 - $130,000.00. 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.

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, please contact: 1-202-419-7762 or [e-mail].

For more information, visit www.danaher.com. 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. Please read our Applicant Data Privacy Notice carefully here.