Danaher Corporation logo
Danaher Corporation

Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home.

Clinical Research Associate

Location

United States

Posted

2 days ago

Salary

$85K - $95K / year

Seniority

Mid Level

No structured requirement data.

Job Description

Clinical Research Associate

Danaher Corporation

Role Description The Clinical Research Associate (CRA) is responsible for set-up, initiation, execution, monitoring, and close-out of IVD and medical device clinical trials at external clinical research sites and/or laboratories. The CRA should be able to solve problems and analyze possible solutions using technical experience and judgement, while receiving a moderate level of guidance and direction. This position reports to the Manager, Clinical Site Operations and is part of the Global Clinical Affairs organization. The position will be fully remote within the United States. In this role, you will have the opportunity to: - 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. 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. Requirements - Ability to travel 20-70%– including overnight(s), within the US. Travel may be up to 70% during project initiation periods. Benefits - Comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. - Flexible, remote working arrangements for eligible roles. - Annual salary range of $85,000 - $95,000. - Eligible for bonus/incentive pay.

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