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Danaher Company DescriptionAt Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for abetter wayand help make life better for us all! For more details, visit us atwww.cepheid.comor follow us on Twitter (@CepheidNews).Description
Job Description Summary
Designs, plans and implements the overall direction of clinical research projects. Evaluates and analyzes clinical data. Must have knowledge in reference to good clinical practices regulations and standard operating procedures. Coordinates activities of associates and investigators to ensure compliance with protocol and overall clinical objectives. Maintains a high level of professional expertise through familiarity with clinical literature and participates in project team meetings. May draft materials including informed consent documents, draft source documents, patient instruction guides and case report forms. Conducts clinical monitoring of field sites to supervise and coordinate clinical studies. May write protocols. May require travel to field sites.
Job Description
KEY RESPONSIBILITIES INCLUDE (but are not limited to):o Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.o Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products.o Assist with the management of key study parameters (i.e. start-up activities, preparation of precision study specimens, data collection and data analysis, etc.)o 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.o Stay up to date on major advances in infectious disease diagnosis, cancer detection and the use of new tests and advances in clinical practiceQualificationREQUIRED KNOWLEDGE, SKILLS AND ABILITIES:The ideal candidate will have the following:
Bachelor’s degree with 0-2 years of related work experience in scientific discipline (Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or Human Physiology), RN or BSN degree or equivalent.
Minimum of 1 year experience with In Vitro Diagnostic (IVD) products.
Experience in monitoring sites, excellent team skills, ability to prioritize and multi-task in a fast-paced environment.
Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
Experience in the handling and shipping of Biohazardous 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.
Familiar with clinical literature in field of study and related areas.
30-50% travel required
Danaher Corporation OverviewDanaher 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: CepheidJob Function: SciencePrimary Location: North America-North America-United States-IL-ChicagoSchedule: Full-timeReq ID: CEP003758Cepheid is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
