Remote Clinical Research Associate – Diagnostics

Leica Biosystems Inc.; Austin (TX); Remote; USD 85,000 - 95,000; Full time

Job summary

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to set up, initiate, execute, monitor and close-out IVD and medical device trials at external sites. The CRA reports to the Manager, Clinical Site Operations and the role is fully remote within the United States.

Responsibilities include overseeing protocol execution, site relationship management, trial monitoring, IRB submissions, and study documentation.

Qualifications

• Bachelor’s degree with 2+ years clinical research experience OR Master’s degree 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

Responsibilities

• Oversee protocol execution at external sites from start-up to close-out.
• Develop and maintain relationships with institutions, investigators, internal stakeholders, and vendors.
• Conduct study monitoring, site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events.
• Manage IRB submissions and all study regulatory documentation.
• Contribute to study planning including budget and timeline forecasts, site identification and qualifications, and process improvement initiatives.

Skills

Regulatory knowledge

GCP compliance

Clinical monitoring

IRB submissions

Site management

Education

Bachelor’s degree

Master’s degree

Tools

eTMF systems

CTMS

Job description

Danaher Diagnostics is seeking a Clinical Research Associate (CRA) to set up, initiate, execute, monitor and close-out IVD and medical device trials at external sites. The CRA reports to the Manager, Clinical Site Operations and the role is fully remote within the United States.

Responsibilities include overseeing protocol execution, site relationship management, trial monitoring, IRB submissions, and study documentation.