Senior Clinical Research Associate

Job not on LinkedIn

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $103k - $130k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Set up, initiate, execute, monitor, and close out IVD and medical device clinical trials at external clinical research sites and/or laboratories • Independently train and manage external clinical research sites • Oversee clinical study protocol execution from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice • Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors • Conduct independent study monitoring, including site coordination and investigational product accountability • Assess protocol deviations and/or adverse events and drive clinical data quality • Follow up on incomplete data entry and outstanding queries • Manage IRB submissions and study regulatory documentation • Keep the Trial Master File up to date and audit ready • Contribute to study planning, budget and contract negotiation, timeline forecasts, site identification and qualifications, and process improvement initiatives • Prepare study documents and create clinical templates, including informed consent forms and clinical monitoring plans

🎯 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 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 • Retrospective/prospective biological sample procurement experience preferred • Experience with electronic Trial Master Files and Clinical Trial Management Systems preferred • Demonstrated understanding of CLSI standards and their application to IVD clinical studies preferred

🏖️ Benefits

• Health care program • Paid time off • Medical insurance • Dental insurance • Vision insurance • 401(k) • Bonus/incentive pay • Flexible, remote working arrangements for eligible roles • Remote work from home