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Danaher Corporation Clinical Research Associate I - (Sunnyvale, CA or Chicago, IL) in Sunnyvale, California

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.

The Clinical Research Associate is responsible for Site management and monitoring. The ideal candidate will have the opportunity to identify sites and responsible for study start up activities to get them up and running for preclinical and clinical studies across infectious disease, sexual health, virology and oncology.

This position is part of the Clinical Affairs Group and will be located in Sunnyvale, CA. The group has three openings due to significant growth which can be based at our site in Sunnyvale, CA or Chicago, IL. This will be a partially remote role. Onsite training is important for the success in this role.

In this role, you will have the opportunity to:

  • Review on-site files, product accountability logs, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance; identifies deficiencies and discrepancies and provides remedial training and/or corrective action as the need arises.

  • Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits.

  • Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.

  • Completion of monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies and recommended action to secure compliance.

  • Ensure that studies adhere to FDA regulations, Good Clinical Practices, and IVD directives.

The essential requirements of the job include:

  • Bachelor's degree in a scientific field (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent with 0-2 years related work experience

  • Experience with Microsoft Office Applications, such as Word, Excel, PowerPoint etc.

  • Clinical Exposure - knowledge of GCP & ICH guidelines and FDA regulations for clinical trials.

  • Ability to travel 30-50% as required to clinical sites

  • 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.

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

  • Knowledge of and experience with In Vitro Diagnostic (IVD) products.

  • Knowledge of conduct of clinical trials and with some in-house monitoring experience.

Cepheid, a Danaher company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

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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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

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.

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 (https://www.dol.gov/agencies/ofccp/posters) .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 you’ve ever wondered what’s within you, there’s no better time to find out.

Operating Company: Cepheid

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