Sr. Clinical Research Associate

Sr. Clinical Research Associate (Sr. CRA)

The Sr. Clinical Research Associate (Sr. CRA) is responsible for the set‑up, initiation, execution, monitoring and close‑out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. The Sr. CRA should be able to independently train and manage external clinical research sites. This position reports to the Manager, Clinical Site Operations and is part of the Global Clinical Affairs organization.

The role is fully remote within the United States.

• 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 independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events; drive clinical data quality, including follow‑up on incomplete data entry and/or outstanding queries.
• Manage IRB submissions and all study regulatory documentation to maintain an audit‑ready Trial Master File.
• Contribute to study planning including budget and contract negotiation, timeline forecasts, site identification and qualification, and process improvement initiatives within the Global Clinical Affairs organization; prepare study documents such as informed consent forms and clinical monitoring plans.

• Bachelor's degree with 5+ years clinical research experience OR Master's degree with 3+ years clinical research experience OR Doctoral degree in the field 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.

• Ability to travel 20-70% of the time, including overnight stays, within the United States; travel may increase to 70% during project initiation periods.

• Retrospective/prospective biological sample procurement.
• Experience with electronic Trial Master Files and Clinical Trial Management Systems.
• CLSI guidelines and Good Laboratory Practice (GLP).

Benefits:
We offer a comprehensive benefits package that includes paid time off, medical/dental/vision insurance and a 401(k) plan to eligible employees. The annual salary range for this role is $ – $, and the position is eligible for bonus/incentive pay.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and provide reasonable accommodations for applicants and employees with disabilities.