Clinical Research Associate
4 weeks ago
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 which makes everything possible.
The Clinical Research Associate is responsible for carrying out the responsibilities involved in the execution of 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 Clinical Operations and will be located in Solna, Stockholm, Sweden and requires 30-50% travelling to Europe, Africa and Asia. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
Identify potential investigators, prepare site budgets and contract agreementsCollect, review and process regulatory documents and correspondence from participating trial sites
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 required.
Provide site support for remote/electronic data capture (EDC), review for completeness and consistency, and generate and resolve queries in between monitoring visits
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:
At least a Bachelor’s degree within Life Sciences, Engineering or related. 2+ Experience in monitoring international sites (independent experience in monitoring, experience in global studies) Knowledge of GCP & ICH guidelines and FDA regulations Fluent level of English Ability to travel 30-50% in Europe, Africa and Asia.It would be a plus if you also possess previous experience in:
Submission to IRB/Ethical committees IVD knowledge Experience with Department of Defense (DOD)Cepheid, a Danaher operating 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 benefits at danaherbenefitsinfo.com.
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.
At Danaher, 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.
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