Danaher Corporation Clinical Research Associate II in Solna, Sweden
Cepheid is a leading molecular diagnostics' company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. We develop and manufacture diagnostics tests, based on real-time PCR, that improve patient outcome all over the world.
We are now opening up the role Clinical Research Associate with possibility of working remote in Europe.
The Clinical Research Associate at Cepheid is primarily 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.
Perform internal performance testing such as proficiency and system testing
Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products
Identify potential investigators, prepare site budgets and contract agreements
Collect, 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.
Develop and implement study specific tracking tools to aid in monitoring, regulatory document review, and follow up of issue resolution
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
We believe that the ideal candidate holds
a Bachelor's degree in a scientific field (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), combined with 3-4 years of experience with In Vitro Diagnostic (IVD) products. The following experience will most likely qualify you for the role:
Experience in monitoring sites, ability to prioritize and multi-task in a fast-paced environment
Excellent communication and team skills
Effective interpersonal skills
Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
Experience in the handling and shipping of Bio hazardous specimens.
Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
Knowledge of GCP & ICH guidelines and FDA regulations
Solid understanding of the diagnostic field and clinical trial material that is to be studied
Experience with laboratory automation and biological databases
Knowledge of good clinical trial design, including the number and types of subjects and specimens that will be required, the conditions under which specimens must be collected, and the current gold standard for the diagnosis of disease
Have attention to details, with strong time management and organizational skills
30% travel required
There is possibility of being based in Solna, Sweden, or any of our other sites in Europe. Travelling is part of the role and it is therefore a plus if you are located near an airport.
Want to join us?
We offer to be a part of an international, fast-paced and fast-growing, but yet friendly and diverse company, where we find it meaningful to go to work. We take ownership in caring for our employees, and also offer a wide range of benefits. Together we work hard to make a difference!
We are interviewing continuously, so make sure to submit your CV today so that we can get to know you!
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team!
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid