Clinical Research Associate I at Lensa Sunnyvale, CA

lop 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 which makes everything possible. The Clinical Research Associate I at Cepheid is primarily responsible for carrying out the responsibilities involved in the execution of in vitro diagnostics (“IVD”) clinical trials. This includes site initiation, monitoring and close-out of clinical trial sites. Clinical trials may be carried out at various stages or phases in the life cycle of the product including alpha (early-stage feasibility), beta and most importantly the clinical studies that validate the product. This position is part of the Clinical Affairs department and will be remote in the United States. In This Role, You Will Have The Opportunity To
• Identify potential investigators, prepare site budgets and contract agreements.
• Collect and review in-house and on-site Trial Master File (TMF), 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 required.
• Provide site support for electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits.
• Completion of monitoring/trip 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 Food and Drug Administration (FDA) regulations, Good Clinical Practices (GCP), International Council for Harmonisation (ICH) guidelines, and IVD directives.
The Essential Requirements Of The Job Include
• Bachelor’s degree in Biological Sciences with 0+ years of related work experience within the clinical research industry;
• Strong oral and written communication skills;
• Experience with Microsoft office (Word, Excel, and PowerPoint)
Travel, Motor Vehicle Record & Physical/Environment Requirements
• 30-50% travel required domestically and internationally
It would be a plus if you also possess previous experience in:
• Experience with in vitro diagnostic clinical trials;
• Knowledge of GCP, ICH guidelines, and FDA regulations;
• Previous hands-on experience in clinical research at either a diagnostic company, hospital or laboratory;
• Previous experience as a clinical trial assistant or equivalent;
• Experience with electronic trial master file (eTMF) tools.
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. Check out our . At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide. The salary range for this role is $56,200 - 84,200. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. Join our winning team today. Together, we’ll 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. For more information, visit . 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 to request accommodation. Operating Company: Cepheid
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