TheSr. Clinical Research Associate(Sr. CRA)is responsible forset-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 positionreports to theManager, Clinical SiteOperationsandis part of theGlobal 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, ensuringtimelydata collection and compliance with FDA standards and Good Clinical Practice (GCP)
• - Develop andmaintainrelationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, dataintegrityand adherence to project requirements
• - Conductindependentstudy monitoring, including site coordination, investigational product accountability,andassessments of protocol deviations and/or adverse events, and driveclinical data qualitywhich canincludefollow up on incomplete data entry and/or outstanding queries
• - Manage IRB submissions and all study regulatory documentationtoensure Trial Master File is kept up to date and audit ready
• - Contribute to study planning including budgetand contract negotiationand 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.

The essential requirements of the job include:

• - Bachelors degree with 5+ years clinical research experience OR Masters degree with 3+ years clinical research experienceOR Doctoral degree in 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

• - Previousexperience with managing clinical research sites andmonitoringclinical study data

• - Good technical background to understand and communicate current andnew technologies

• - Ability to work on multiple projects simultaneously

Travel Requirements:

• - Ability to travel 20-70%includingovernight(s), within the US. Travel may be up to 70% during project initiation periods

It would be a plus if you also possess previous experience in:

• - Retrospective/prospective biological sample procurement
• - Experience withelectronicTrial Master Filesand Clinical TrialManagement Systems
• - CLSI guidelines and Good Laboratory Practice (GLP)

Within Danaher Diagnostics, we offer a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at .

Within Danaher 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. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working within Danaher Diagnostics can provide.

The annual salary range OR the hourly range for this role is $103,000.00 - $130,000.00. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law.