Clinical Research Associate (CRA)

Danaher is a life sciences and diagnostics company focused on accelerating innovation in precision diagnostics. The Clinical Research Associate is responsible for setting up, initiating, executing, monitoring, and closing out IVD and medical device clinical trials while ensuring regulatory compliance, data integrity, and successful site performance.

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

Preferred

Retrospective/prospective biological sample procurement

Experience with electronic Trial Master Files and Clinical Trial Management Systems

Demonstrated understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision/reproducibility, reference interval, specimen stability, clinical performance, and point-of-care evaluations

Biological Sample Procurement

Electronic Trial Master Files

Clinical Trial Management Systems

CLSI Standards

IVD Clinical Studies

Method Comparison

Precision

Reproducibility

Reference Intervals

Specimen Stability

Clinical Performance

Point-of-Care Evaluation

Benefits

Bonus/incentive pay

Paid time off for eligible employees

Medical insurance for eligible employees

Dental insurance for eligible employees

Vision insurance for eligible employees

401(k) for eligible employees

This position is eligible for a remote work arrangement in which you can work remotely from your home.

Company

Life sciences and diagnostics technologies for human health

Washington, District of Columbia, USA

https://www.danaher.com/

Founded in 1984

10001+ employees

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

Retrospective/prospective biological sample procurement

Experience with electronic Trial Master Files and Clinical Trial Management Systems

Demonstrated understanding of CLSI standards and their application to IVD clinical studies, including method comparison, precision/reproducibility, reference interval, specimen stability, clinical performance, and point-of-care evaluations

Bachelor’s degree with 2+ years clinical research experience OR Master’s degree with 0-2 years clinical research experience

Required skills

Clinical Research, IVD and Medical Device Clinical Trials, Clinical Practice (GCP), FDA Regulatory Requirements, Clinical Research Site Management, Clinical Study Monitoring, Electronic Trial Master Files (eTMF), Clinical Trial Management Systems (CTMS), CLSI Standards, Biological Sample Procurement

Preferred skills

Retrospective/prospective biological sample procurement

Experience

Mid level