Full-time
Clinical Research Associate (CRA)
$85K/yr – $95K/yr
Medical, dental and vision insurance for eligible employeesScience & PharmaceuticalPosted 29d ago
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Role overview
Job type
Salary
$85K/yr – $95K/yr
Sector
Posted
29 days ago
Job description
Danaher is a life sciences and diagnostics company focused on advancing diagnostic technologies and improving health outcomes. The Clinical Research Associate oversees the setup, execution, monitoring, and close-out of IVD and medical device clinical trials, ensuring protocol compliance, data integrity, regulatory adherence, and effective collaboration with clinical sites and stakeholders.
Tags
Life Science
Biotechnology
Manufacturing
Insider Connection @Beckman Coulter Life Sciences
2 email credits available today
Beyond your network
Maya K.
Sr. Clinical Research Associate
From your previous company
& 2 connections
Previously@undefined and...
from your School
Responsibilities
Oversee clinical study protocol execution at external sites, from start-up to close-out, ensuringtimelydata collection and compliance with FDA standards and Good Clinical Practice (GCP)
Develop andmaintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, dataintegrityand 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
Benefits
This job is also eligible for bonus/incentive pay.
Paid time off for eligible employees
Medical, dental and 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.
Beckman Coulter Life Sciences develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests.
Indianapolis, Indiana, USA
https://www.mybeckman.uk/
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Management and Executive
Product Management
Accounting and Finance
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Marketing
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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, Clinical Practice (GCP), IVD and Medical Device Regulatory Requirements, Clinical Research Site Management, Clinical Study Data Monitoring, Institutional Review Board (IRB) Submissions, Electronic Trial Master Files (eTMF), Clinical Trial Management Systems, CLSI Standards, Biological Sample Procurement
Preferred skills
Retrospective/prospective biological sample procurement
Experience
Mid level
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