Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Clinical Research Associate for Beckman Coulter Diagnostics is responsible for supporting clinical trial activities including biobanking to generate clinical evidence that will support product design, registration and/or product market clearance/approval.

This position is located onsite in our Chaska, MN facility and will hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time!

You will be a part of the Clinical Affairs Team and report to the Senior Manager of Clinical Affairs responsible for Immunoassay and Clinical Chemistry Clinical Evidence Generation. If you thrive in a fast-paced, innovative role and want to work to build a world-class Clinical Affairs organization—read on.

In this role, you will have the opportunity to:

• Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
• Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
• Onsite and/or remote monitoring of data and overseeing corrective actions.
• Drive schedule deliverables to meet the overall study timelines.
• Develop and drive centralized processes to sample banking.
• Support clinical team which may include activities related to budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, and vendor support activities.
• Manage shipping of instrument consumables, investigational-use-only (IUO) products, and de-identified human specimens within required temperature conditions.
• Adherence to PHI protection and GCP

The essential requirements of the job include:

• Bachelor's degree or equivalent in the life sciences, with 2+ years’ work experience in vitro diagnostics (IVD), Medical Device, or Healthcare clinical field; 0 years’ of experience with Master’s degree, or 0+ years with Doctoral degree.
• Demonstrated agility with processes and details, ability to apply critical thinking, analyze data (using analytical tools), and solve complex problems.
• Ability to work independently and effectively under a fast-paced and changing environment.
• Proficiency Microsoft Office Excel and Outlook
• Able to be in the office 2-3 days weekly to the Chaska office as needed.

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

• Freezer Pro System, Freezer Validation and/or Rees Monitoring System
• CLSI guidelines and Good Laboratory Practice (GLP)
• Electronic data capture (EDC) system and eTMF system (Florence)
• Clinical research certification (i.e., SOCRA, CCRA, CCRC)

#LI-MR1

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

In this role, you will have the opportunity to:

• Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
• Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
• Onsite and/or remote monitoring of data and overseeing corrective actions.
• Drive schedule deliverables to meet the overall study timelines
• Develop and drive centralized processes to sample banking.
• Support clinical team which may include activities related to budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, vendor support activities
• Manage shipping of instrument consumables, investigational-use-only (IUO) product, de-identified human specimens within required temperature conditions
• Adherence of PHI protection and GCP

The essential requirements of the job include:

• Bachelor's degree or equivalent in the life sciences, with 2+ years’ work experience in vitro diagnostics (IVD), Medical Device, or Healthcare clinical field; 0+ years’ experience with Master’s degree, or 0+ years with Doctoral degree.
• Demonstrated agility with processes and details, ability to apply critically-thinking, analyze data (using analytical tools), and solve complex problems.
• Ability to work independently and effectively under a fast-paced and changing environment
• Proficiency Microsoft Office Excel and Outlook
• Able to travel 50%+ during to the Chaska office as needed

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

• Freezer Pro System
• CLSI guidelines and Good Laboratory Practice (GLP)
• Electronic data capture (EDC) system and eTMF system (Florence)
• Clinical research certification (i.e., SOCRA, CCRA, CCRC)

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.