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Senior Clinical Research Associate
Danaher CorporationOverseeing clinical trials for IVD and medical devices within Danaher Diagnostics. Ensuring compliance and developing relationships with stakeholders across the industry remotely in the US.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Oversee clinical study protocol execution at external sites
- Ensure 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
- Conduct independent study monitoring, including site coordination and investigational product accountability
- Manage IRB submissions and all study regulatory documentation
- Contribute to study planning including budget and contract negotiation
Requirements
What you’ll need- 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
Benefits
Comp & perks- Competitive benefit programs including health insurance
- Paid time off
- 401(k) plan
- Flexible working arrangements
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical study protocol executiondata collectionFDA standardsGood Clinical Practice (GCP)study monitoringsite coordinationinvestigational product accountabilityIRB submissionsregulatory documentationbudget and contract negotiation
Soft Skills
relationship managementcommunicationorganizational skillsmultitasking
Certifications
Bachelor’s degreeMaster’s degreeDoctoral degree