Job Description

Clinical Research Associate II at Danaher Diagnostics oversees setup, execution, and closeout of IVD and medical device clinical trials at external sites. Reports to Manager of Clinical Site Operations in a fully remote role within the US, requiring strong regulatory knowledge and multi-project management capabilities.

Responsibilities

• Lead clinical study execution from startup through closeout, ensuring protocol compliance and GCP adherence
• Build and maintain collaborative relationships with investigators, institutions, and cross-functional stakeholders
• Conduct site monitoring activities including oversight, product accountability, and protocol deviation management
• Manage IRB/IEC submissions, amendments, and regulatory documentation for completeness and compliance
• Support study planning including site identification, qualification, activation, and budget negotiations

Requirements

• Bachelor's degree in life sciences, healthcare, or related field plus 3+ years clinical research experience
• Master's degree in related field with 2+ years work experience or equivalent employment history
• Knowledge of regulatory requirements and Good Clinical Practice standards
• Experience with in vitro diagnostic and medical device clinical trials preferred
• Ability to manage multiple concurrent projects and utilize current technologies
• Willingness to travel 20-70% within US, potentially up to 70% during project initiation

Compensation: $75,000-$95,000 base; eligible for bonus/incentive pay

Job Tags

Similar Jobs