Siemens Clinical Research Specialist 2 in Tarrytown, New York
Clinical Research Specialist 2
Locations:Tarrytown, New York
Job Family: Quality Management
Division: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 213768
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 25%
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.
With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.
For more information, please visit: http://www.usa.siemens.com/healthineers
Reporting to a Clinical Project Manager or a Sr Clinical Manager, assist the Clinical Project Manager or Senior Clinical Research Associate in the preparation and execution of clinical study tasks including: documents (may include plan, protocol, report), initiation, monitoring, and completion of clinical studies for verification and/or validation of Siemens Healthcare Diagnostics in vitro diagnostic products (new or modified).
Provides support to project element teams to ensure the project the requirements are met and clinical trials are conducted succesfully.
Ensures adherence to Good Clinical Practice (GCP) and department standard operating procedures for conducting device clinical studies.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Other duties may be assigned.
• Under supervision of a Clinical Affairs’ team member, , provides support on study tasks with relevant departments (R&D, Regulatory Affairs, Medical Affairs, Validations, Product Support, Marketing) to aid in design and preparation of clinical and analytical in vitro diagnostic device performance study plans, protocols, statistical data analysis plans, and associated study data collection forms.
•Remains current with regulatory requirements for in vitro diagnostic products.
• With some supervision, assists in all activities related to the set-up, initiation, execution and close-out of in vitro diagnostic device clinical trials including specimen collection, timely review and analysis of data generated.
• Provides assistance during on-site monitoring visits to ensure protocol compliance, accuracy and completeness of clinical data.
• Communicates with study investigators via phone, fax, email and/or letters regarding activities in all phases of the study. Develops and maintains ongoing relationships with investigators/institutions/vendors with access to specimens needed in clinical trials.
•Participate in coordinationwith biostatisticiansand data managersto manage incoming clinical site data, design/maintain databases, and ensure integrity of the database.
•Support preparation ofup-to-date clinical study progress.
•Supports the tracking of study budgets, site contract origination and compliance approval for studies.
• Assists Clinical Affairs Supervisor with preparation of responses to regulatory agencies.
• Assists in the preparation of scientific abstracts, posters, and publications reporting results of the clinical studies.
Equal Employment Opportunity Statement
Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.
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Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .
Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .