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Job Title: Senior Clinical Research Associate
Company Name: Beckman Coulter Diagnostics
Location: Chaska, MN United States
Position Type: Full Time
Post Date: 06/07/2022
Expire Date: 07/07/2022
Job Categories: Biotechnology and Pharmaceutical, Healthcare, Other, Healthcare, Practitioner and Technician, Information Technology, Installation, Maintenance, and Repair, Research & Development, Medical
Job Description
Senior Clinical Research Associate

Wondering whats within Beckman Coulter? Take a closer look.

At first glance, youll see that for more than 80 years weve 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. Were building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and youll 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, were working at the pace of change to improve patient lives with diagnostic tools that address the worlds biggest health challenges!

The Sr. Clinical Research Associate for Beckman Coulter Diagnostics is responsible for providing expert and overall support to clinical study teams and for all key phases of the assigned clinical studies, including planning, execution, analysis, reports & close-out.

This position is part of the Beckman Coulter Chemistry & Immunoassay business and will be hybrid in Chaska, MN or may be remote. At Beckman we take great research and generate the evidence to create an easy to use and highly reliable product.

This position is on the Clinical Affairs Team and reports to the Lead Clinical Research Associate of Clinical Operations responsible for planning and execution of a portfolio of both pre-market and post-market clinical research programs for the Chemistry & Immunoassay business.

In this role, you will have the opportunity to:

  • Participate in the key phases of the external clinical study, including planning, execution, analysis & close-out. This includes drafting the necessary documents for each phase.
  • Support final study site selection, contract process and site initiation visits; participates in investigators meetings and other training of site personnel on the clinical study protocol, database, and investigator responsibilities.
  • Execute the clinical study monitoring plan, with interim and risk-based monitoring visits to verify site compliance to the study protocol and applicable regulations.
  • Review data and support database development and maintenance with selected database vendor representatives.
  • Supports final study site selection, contract process and site initiation visits; participates in investigators meetings and other training of site personnel on the clinical study protocol, database, and investigator responsibilities.

The essential requirements of the job include:

  • Bachelors degree with 5+ years of experience clinical research (IVD, pharma, medical device), or Masters degree with 3 years of experience, or Doctorate with 1-2 years.
  • Experience with clinical study management and monitoring for clinical diagnostics, medical devices or pharmaceutical products in a regulated environment.
  • Functional knowledge of Good Clinical Practice, certification a plus, and familiar with US and OUS requirements for design control and clinical study management.
  • Experience working with data management tools and understanding of databases and general statistical concepts.
  • Willing and able to develop appropriate internal or external technical expertise required and coordinate efforts to resolve technical issues that may arise during clinical trials.
  • Able to travel up to 30% of the time, depending on business needs.

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

  • Clinical research certification (such as CCRA, CCRC)

Danaher is committed to a diverse and inclusive culture where everyone feels they belong, and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why well empower you to push the boundaries of whats possible.

When you join us, youll also be joining Danahers global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, youll 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.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

The EEO posters are available here.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.

If youve ever wondered whats within you, theres no better time to find out.

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Company Name: Beckman Coulter Diagnostics
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Website:https://jobs.danaher.com/global/en/job/DANAGLOBALR1207024EXTERNALENGLOBAL/Senior-Clinical-Research-Associate?utm_source=hbcuconnect&utm_medium=phenom-feeds
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