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Danaher Corporation develops life sciences and diagnostic technologies used in scientific research, biotechnology, and clinical testing. Its businesses provide instruments, software, technologies, and services for academic institutions, pharmaceutical and biotechnology companies, and clinical laboratories, with a focus on biotechnology tools, diagnostics platforms, and other life sciences products. The company manages its operations through the Danaher Business System and grows its portfolio through acquisitions that expand its technology and customer reach.
Senior Clinical Research Associate, IVD and Medical Devices — Remote US
Lead clinical research activities for Danaher Diagnostics across in vitro diagnostic and medical device trials. Manage study sites, monitor data, and support compliance with FDA requirements and Good Clinical Practice.
Description
- Establish, launch, conduct, monitor, and close out IVD and medical device trials at external research sites and laboratories.
- Train and oversee external clinical research sites independently.
- Manage protocol execution from study start-up through close-out, maintaining timely data collection and FDA and Good Clinical Practice compliance.
- Build effective working relationships with institutions, investigators, internal partners, and vendors.
- Perform independent study monitoring, including site coordination and investigational product accountability.
- Evaluate protocol deviations and adverse events while advancing clinical data quality.
- Resolve incomplete data entry and outstanding data queries.
- Coordinate IRB submissions and maintain regulatory study records.
- Maintain an accurate, audit-ready Trial Master File.
- Support study planning, budget and contract negotiations, timeline forecasting, site identification and qualification, and process improvement.
- Develop study documentation and clinical templates, including informed consent forms and clinical monitoring plans.
Requirements
- Bachelor’s degree and at least five years of clinical research experience, master’s degree and at least three years of clinical research experience, or a doctoral degree in a relevant field with clinical research experience.
- Working knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.
- Experience managing clinical research sites and monitoring clinical study data.
- Technical expertise sufficient to understand and communicate current and emerging technologies.
- Ability to manage multiple projects concurrently.
- Willingness to travel 20–70%, including overnight travel, within the United States.
- Experience procuring retrospective or prospective biological samples is preferred.
- Experience using electronic Trial Master Files and Clinical Trial Management Systems is preferred.
- Understanding of CLSI standards and their application to IVD clinical studies is preferred.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus or incentive pay
- Flexible remote work arrangements for eligible roles
- Work-from-home arrangement
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