Senior Clinical Research Associate

Job not on LinkedIn

🕒 3 days ago

🇺🇸 United States – Remote

💵 $103k - $130k / year

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

🔬 Science

🤝 B2B

Biotechnology • Science • B2B

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• 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.

🎯 Requirements

• 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 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

🏖️ Benefits

• Paid time off • Medical/dental/vision insurance • 401(k) to eligible employees • Bonus/incentive pay