Remote Clinical Research Associate (IVD Trials)

Danaher Corporation; United States; Remote; USD 85,000 - 95,000; Full time

Benefits offered by this job

Remote work arrangements

Benefits package

Job summary

The Clinical Research Associate (CRA) role at Danaher Diagnostics offers remote work within the United States. You’ll manage set-up, initiation, monitoring and close-out of IVD and medical device trials at external sites, solving problems with technical judgment and guidance.

You will collaborate with clinical sites, investigators, and vendors, ensuring data integrity, regulatory compliance, and timely study milestones, while supporting IRB submissions and study documents.

Qualifications

• Bachelor's degree with 2+ years clinical research experience or Master's degree with 0-2 years clinical research experience.
• 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 clinical study protocol execution at external sites, from start-up to close-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP)
• Develop and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data integrity and adherence to project requirements
• Conduct study monitoring, including 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 within the Global Clinical Affairs organization; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc.

Education

Bachelor's degree + 2+ years clinical research

Master's degree + 0-2 years clinical research

Job description

The Clinical Research Associate (CRA) role at Danaher Diagnostics offers remote work within the United States. You’ll manage set-up, initiation, monitoring and close-out of IVD and medical device trials at external sites, solving problems with technical judgment and guidance.

You will collaborate with clinical sites, investigators, and vendors, ensuring data integrity, regulatory compliance, and timely study milestones, while supporting IRB submissions and study documents.