Senior Clinical Research Associate
Beckman Coulter Diagnostics

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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 Senior Clinical Research Associate for Beckman Coulter Diagnostics is responsible for monitoring the in-house blood draw program and coordinating the efforts to add new study sites to the program.

This position is part of the Clinical Chemistry and Immunoassay (CCIA) Clinical Affairs Department located in Chaska, MN and will be on-site. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the CCIA Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a cross-functional, detail-oriented role and want to work to build a world-class Clinical organization-read on.

In this role, you will have the opportunity to:

• Set up the in-house blood draw program across US and OUS Beckman Coulter locations, ensuring the program meets the needs of cross-functional teams and complies with GCP, IRB policies and procedures, and applicable Standard Operating Procedures (SOP).
• Conduct onsite and remote monitoring visits (SIV, IMV, COV) to perform proactive document/data review to identify discrepancies and protocol deviations, overseeing corrective actions to drive compliance with study protocol(s). Effectively escalate and collaborate with site personnel and internal team members to propose solutions to sustain good compliance.
• 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 current; assist in audit readiness and preparation.
• Support the in-house biorepository by receiving, shipping, and tracking clinical study samples.
• May perform other clinical project activities such as drafting documents, reports, data summaries, presentations, conducting literature searches, publication and/or podium planning.

The essential requirements of the job include:

• Bachelor of Science degree in the life sciences or related field required with 5+ years of experience in vitro diagnostics (IVD), medical device, or healthcare clinical field.
• Demonstrated agility with processes and details, ability to apply critical thinking and solve complex problems.
• Effectively communicate with internal and external stakeholders who possess various levels of clinical research experience.
• Ability to independently complete IRB submissions (initial review, change in research, continuing review, closeout report).
• Thorough understanding of Good Clinical Practice (GCP).

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

• Global Clinical Trials Monitoring/Management
• Experience with electronic Trial Master Files
• Project Coordination/Management

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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