Clinical Research Associate (CRA)

Clinical Research Associate at Danaher responsible for managing IVD and medical device clinical trials at external sites, from initiation through close-out. The role involves site oversight, regulatory compliance, data monitoring, and stakeholder coordination within a fully remote position reporting to Clinical Site Operations.

Responsibilities

• Oversee clinical study protocol execution at external sites from startup through closeout with FDA and GCP compliance
• Develop and maintain relationships with institutions, investigators, stakeholders, and vendors for successful trial execution
• Conduct study monitoring including site coordination, product accountability, and protocol deviation assessment
• Manage IRB submissions and regulatory documentation for clinical studies
• Contribute to study planning including budget forecasting, site qualification, and process improvements

Requirements

• Bachelor's degree with 2+ years clinical research experience, or Master's degree with 0-2 years
• Knowledge of regulatory requirements and Good Clinical Practice for IVD and medical device products
• Experience managing clinical research sites and monitoring study data
• Technical background to understand and communicate diagnostic and medical device technologies
• Ability to manage multiple concurrent projects
• Willingness to travel 20-70% domestically, up to 70% during project initiation

Compensation: $85,000 - $95,000 annual salary; eligible for bonus/incentive pay