Remote Senior Clinical Research Associate

Danaher; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits program

Job summary

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead set-up, initiation, execution, monitoring, and close-out of IVD and medical device trials at external sites within the United States. The role requires independence in training and managing external sites and reports to the Manager, Clinical Site Operations.

The position is fully remote in the U.S. and involves travel; essential experience includes regulatory knowledge, GCP, and site management.

Qualifications

• Bachelor’s degree plus 5+ years clinical research experience, or higher degrees with related experience.
• Knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.
• Experience managing clinical research sites and monitoring study data.
• Ability to work across multiple projects and communicate current technologies.

Responsibilities

• Oversee protocol execution at external sites from start-up to close-out, ensuring data collection and GCP compliance.
• Develop and maintain relationships with institutions, investigators, and vendors for trial success and data integrity.
• Conduct independent study monitoring and assess deviations and adverse events; drive data quality.
• Manage IRB submissions and Trial Master File to ensure audit readiness.
• Assist study planning including budgeting, contracts, timelines, site selection, and templates creation.

Skills

Regulatory knowledge

Clinical research experience

Project management

Communication skills

Travel readiness

Education

Bachelor's degree

Master's degree

Doctoral degree

Tools

EDC software

CTMS

TMF systems

Job description

Danaher Diagnostics is seeking a Sr. Clinical Research Associate to lead set-up, initiation, execution, monitoring, and close-out of IVD and medical device trials at external sites within the United States. The role requires independence in training and managing external sites and reports to the Manager, Clinical Site Operations.

The position is fully remote in the U.S. and involves travel; essential experience includes regulatory knowledge, GCP, and site management.