Note: The job is a remote job and is open to candidates in USA. Danaher is a life sciences and diagnostics company focused on accelerating innovation in precision diagnostics. The Clinical Research Associate II will execute and monitor in vitro diagnostic and medical device clinical trials across external sites, ensuring protocol compliance, data integrity, regulatory adherence, and timely study delivery.
Responsibilities
- Lead clinical study execution across external sites from start-up through close-out, ensuring protocol compliance, timely data collection, issue resolution, and adherence to GCP and regulatory requirements
- Build and maintain collaborative relationships with investigators, institutions, vendors, and cross-functional stakeholders to support study delivery, data integrity, and project objectives
- Conduct study monitoring activities, including site oversight, investigational product accountability, and management of protocol deviations and adverse events, driving appropriate corrective and preventive actions
- Manage IRB/IEC submissions, amendments, and study regulatory documentation, ensuring completeness and compliance with applicable regulations
- Support study planning and execution through site identification, qualification, activation, contract and budget negotiations, and continuous process improvement initiatives within Global Clinical Affairs
Skills
- Bachelor's degree (Life Sciences, Healthcare, or a related field preferred) with 3+ years clinical research experience OR Master's degree in field with 2+ years of related work experience, or demonstrated employment equivalency
- Proven knowledge of regulatory requirements and Good Clinical Practice
- Strong technical background with ability to utilize current and emerging technologies
- Ability to work on multiple projects simultaneously
- Ability to travel 20-70%– including overnights, within the US. Travel may be up to 70% during project initiation periods
- Experience with in vitro diagnostic (IVD) and medical device clinical trials (preferred)
- Experience with electronic Trial Master Files (eTMF), Electronic Data Capture (EDC) systems, and Clinical Trial Management Systems (CTMS)
- CLSI guidelines and Good Laboratory Practice (GLP)
- Neurological Disease Research
Benefits
- This job is also eligible for bonus/incentive pay.
- Paid time off for eligible employees
- Medical/dental/vision insurance for eligible employees
- 401(k) for eligible employees
- This position is eligible for a remote work arrangement in which you can work remotely from your home.
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