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Clinical Research Associate_Beijing in Beijing, China at Beckman Coulter Diagnostics

Date Posted: 3/7/2019

Job Snapshot

Job Description

Job ID: BEC013681

About Us

Founded in America by Professor Beckman and the Coulter brothers, Beckman Coulter Limited is dedicated to the to the development and sale of instruments, reagents, software and products that simplify and automate laboratory processing that are widely used in hospitals, clinics, and commercial laboratories worldwide. Clinical diagnostic tools implemented within company products include: laboratory automation systems, biochemical analytical systems, immunoassay systems, hematology systems, protein chemistry systems, urinalysis systems, microbiological detection and analysis systems, and blood bank analytical systems. In future developments, Beckman Coulter will continue to lead in the field of medical equipment research and development with cutting-edge technology and complete product lines, and continue to make outstanding contributions to the development of global scientific research! For more information, please visit www.beckmancoulter.com.


Description

� To work as a project leader for preparing and conducting IVD or other medical advice clinical trials which are needed by registration in China. o Act as a main line with marketing related persons and LSS for the sample ordering o Communicate with CRO or other clinical agency for the trial preparation, such as protocol design o Work with CRO to conduct investigator selection, investigator meeting, and EC submission o Tracking to meet target including source data verification, timeline, enrolled sample number and budget, etc o Co-monitoring with CRA/CRO to ensure trial quality compliance with the requirement of ICH GCP, SOPs and local regulations o Managing document filing according to the requirement of SOP � Make the clinical trial planning and managing to get the clinical report and other required document in a target timeline � Good interface with government agency, manage relationship with vendors, consultants, contractors and professional associations � Adhere to policies and procedures

Job Requirements



Qualifications

This position requires baccalaureate college degree of molecular biology, clinical laboratory medicine, molecular immunology or relevant clinical diagnostic fields and more than 5 years of clinical study experience and/or registration experiences, or advanced degree(s) and 1 year of experience for management expertise. This position also requires: � Be experienced in GCP quality system � Be familiar with regulatory requirement, Chinese & international regulation of medical devices and/or IVD � Resolves routine issues; identifies non-routine issues and may take actions to resolve � Continuously learns from experiences, particularly non-routine challenges � Overcomes potential stumbling blocks to achieve objectives � Understands complex technical and non-technical documentation � Effectively communicates with external contacts to ensure positive outcomes � Excellent team work and influential interpersonal communication skill � Good attitude, well habit of work, positive & take responsibility � Analysis & Judgment � Result oriented � Excellent English skills in speaking, reading and writing

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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 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.