Clinical Research Specialist II

at  Beckman Coulter Diagnostics

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 Specialist II for Beckman Coulter Diagnostics is responsible for conducting biospecimen testing on automated laboratory instruments, and for sample management related to planning and executing in vitro diagnostic (IVD) clinical studies.
This position is part of the 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 Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a fast paced, detail- oriented role and want to work to build a world-class Clinical organization—read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor’s degree required, preferably in a life science field.
• A minimum of 2 years of experience working in a clinical laboratory processing biospecimens, performing IVD testing on automated laboratory instruments by following assay instructions for use and/or research protocols, reporting results, and completing detailed records. Experience in a research and development laboratory may be considered.
• Experience conducting laboratory testing with minimal supervision; ability to resolve routine laboratory problems. Produce high quality test results and records.
• Ability to work effectively within cross-functional teams. Identify and escalate study issues to site personnel and study monitors. Implement solutions to sustain good compliance.
• Knowledge of clinical laboratory, clinical research, and medical terminology.

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Clinical Databases or Electronic Trial Master Files
• Biospecimen receipt, shipment, or tracking
  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.
  Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.

• Work with cross-functional teams to plan and execute internal clinical research studies. Process biospecimens and conduct laboratory testing of biospecimens on automated in vitro diagnostic instruments to generate data for submissions to regulatory authorities. Use lab experience and judgement to analyze testing problems and propose solutions.
• Represent the internal testing site during onsite and remote monitoring visits (SIV, IMV, COV) and proactively review documents/data to identify discrepancies and protocol deviations. Oversee corrective actions to drive compliance with study protocols.
• Regulatory management of Investigator Site Files, document completion, organization, data entry, and quality assurance. Ensure Trial Master File (TMF) records are complete and kept current and assist in audit readiness and preparation.
• Manage the ordering, distribution, and tracking of clinical study supplies, including investigational products and study materials. Maintain detailed, accurate accountability and disposition records.
• Ship, receive, and track clinical study sample shipments. Ensure samples meet stability requirements and escalate sample and shipment issues to the in-house biorepository manager.