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About the Role
The Clinical Research Associate (CRA) is responsible for the setup, initiation, execution, monitoring, and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. This role requires problem-solving abilities and technical judgment with moderate guidance. The position reports to the Manager, Clinical Site Operations within the Global Clinical Affairs organization and is fully remote within the United States.
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 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
- Prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc.
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
- Ability to travel 20-70%– including overnight(s), within the US. Travel may be up to 70% during project initiation periods
Skills
- 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.
Location
- United States
Work Type
- Remote
- Full-time
Experience Level
- 2+ years clinical research experience
- 0-2 years clinical research experience
Education Level
- Bachelor's degree
- Master's degree
Salary/Compensations
- $85,000 - $95,000
Benefits
- Paid time off
- Medical/dental/vision insurance
- 401(k)
- Bonus/incentive pay
About the Company
- Danaher's diagnostic businesses save lives and are united by a shared commitment to innovate for tangible impact.
- Danaher is accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges.
- Danaher drives innovation through partnerships with top academic institutions and leading players in biopharma and translational research.
- Danaher brings the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances.
- Danaher is expanding access to precision diagnostics for millions of people worldwide using its global scale and proven playbook.
- Danaher helps providers, patients, and families get faster, more precise diagnostic results, improving treatment options and saving lives.
- Learn about the Danaher Business System which makes everything possible.
- For more information, visit www.danaher.com.
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.
- We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.