Danaher Corporation Senior Clinical Research Associate in Chaska, Minnesota
Danaher Company Description
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care. Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see. If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or atwww.beckmancoulter.com. Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
* Review of endpoint data (i.e., diagnosis vs investigational results, disease severity, etiology) * Support activities to identify and contract with appropriately qualified disease state experts to serve on the endpoint adjudication committee * Draft and maintain key adjudication documents, including committee charter, data reports and clinical evidence needed for specific clinical study adjudication needs * Plan, schedule, prepare and distribute materials as well as facilitate meetings for endpoint adjudication in compliance to the established charter * Prepare and report metrics for adjudication across assigned studies and programs and support the delivery to study team and key stakeholders * Support clinical study team on draft protocols and reports related to adjudication processes and results as the adjudication subject matter expert * Reconcile to ensure all events requiring adjudication were reviewed by the Clinical endpoint committee * Future longitudinal or companion diagnostics studies may require safety review, adjudication, and safety narratives * Work collaboratively with the study team to ensure scheduled adjudication aligns with critical project milestones * Follow-up with study site manager to obtain additional supporting documentation and materials for potential endpoints or events. * Review data and documentation via hard copy or within an electronic environment to ensure completeness of endpoint or event package, to ensure documents are fully redacted of identifying and blinded details per the protocol and charter, and to identify any unreported potential endpoints or events. * Interface with internal and external functions – physicians, study site research staff, study teams, clinical leadership, data management, and biostatistics. * May be asked to perform other clinical responsibilities as directed by the project or functional leader of Clinical Affairs.
* Bachelor’s degree with 3-5 years’ of relevant IVD, device, or pharmaceutical clinical research experience, advanced degree a plus. * At least one year of experience working in an endpoint review and adjudication role.
* Functional knowledge of Good Clinical Practice, certification a plus, and familiar with US and OUS requirements for privacy laws and clinical study conduct. * Experience working with data management tools, 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 execution of primary activities. * Ability to work in a team environment, with the ability to relate to both highly educated and unskilled team members. * Ability to handle and resolve conflicts and work under stressful conditions and in an environment of changing priorities. * Must be detail-oriented; demonstrate excellent verbal/written communication and interpersonal skills. * Able to travel up to 20% of the time, depending on business need. Education and Experience:
* Bachelor of Science (B.S.), Master of Science (M.S.) or Doctor of Philosophy (Ph.D.) in scientific or related field and a minimum of the following years of industry or relevant experience according to degree:Bachelor’s Degree 3 years, OR Master’s degree with 2 years, OR Doctoral degree with 1-2 years * Language Skills: Must be proficient in writing and communicating in the English language. * Certifications, Licenses, Registrations: Clinical research certification (such as CCRA, CCRC) desired. Diversity & Inclusion At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page—Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.
Danaher Corporation Overview
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 is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Organization: Beckman Coulter - Diagnostics
Job Function: Science
Primary Location: North America-North America-United States-MN-Chaska
Req ID: BEC015040