北京招聘

Job Duties and Responsibilities:

• Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
• Ensures the HGRAC and IRB submission and approval.
• Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines.
• Ensure that the rights and wellbeing of human subjects are protected.
• Ensure the trial data are accurate, complete, and verifiable from source documents.
• Verifies that the investigator is enrolling only eligible subjects.
• Performs verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.
• Ensures that any corrections are appropriately documented by authorized site staff.
• Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.
• Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period.
• Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence.
• Delivers quality written reports, confirmation and follow-up letters within timelines of SOPs and Monitoring Plans.
• Ensure that the trial is conducted and documented properly from study start-up through close-out.
• Participates in site audits, as requested.
• May conduct site and study feasibility assessments.
• May be involved in the development of monitoring guideline and tools.
• Support study monitoring from other BU as needed.
  
  Job Requirements:
  At least 3 years CRA working experience in multinational pharmaceutical, Medical Device company or CRO.
  Have Medical Device or IVD clinical trials experience. Flow cytometry IVD class III experience is required.
  Familiar with clinical trial Quality Management System.
  Good English skills, willing to learn, hard working.
  Candidate should be major in clinical medicine or pharmacy; Pathology would be a plus.         10% domestic travel.

Agilent is a leader in life sciences, diagnostics and applied chemical markets. The company provides laboratories worldwide with instruments, services, consumables, applications and expertise, enabling customers to gain the insights they seek. Agilent’s expertise and trusted collaboration give them the highest confidence in our solutions.

Agilent focuses its expertise on six key markets, where we help our customers achieve their goals:

Food: Agilent helps ensure that our global food supply is free of contaminants—whether chemical, viral, bacterial or microbiological. Our customers include government regulators and labs that control food safety, as well as private companies that produce, package and sell food to the public.

Environmental and Forensics: From pesticides to pharmaceutical residues to trace metals, we provide fast, accurate and sensitive methods for monitoring contaminants affecting quality of life. Agilent solutions also play an important role in law enforcement by providing robust tools and instruments to analyze and verify evidence at trial, and keeping the world’s top-performing athletes honest.

Pharmaceutical: Agilent has one of the broadest solutions portfolios of any company serving the pharmaceutical industry. Our solutions provide precise answers for every segment of the pharmaceutical industry, from disease research and drug discovery to drug development, manufacturing and quality control. The start-to-finish solution set means customers can get products to market faster. Customers trust us to help them test the purity of their therapeutics. Agilent also ensures that their instruments and processes conform to the highest compliance regulations.

Diagnostics: Agilent gives doctors a head start in the fight against cancer and other diseases. Our solutions help pathology laboratories deliver fast, accurate information to the doctors, hospitals and medical centers they serve. We help medical professionals make more accurate diagnoses so patients can receive the most effective therapies.

Chemical and Energy: The world runs on energy, and energy companies need to locate, extract and refine fuels efficiently and cost-effectively. Our solutions help customers maximize their production and predict failures in their refineries before they happen. Agilent also helps energy researchers investigate biofuels, renewable fuels and other forms of alternate energy.

Research: Most life sciences and diagnostics research is done at top-tier universities, with funding from governments around the world. Agilent is helping these researchers learn more about cancer, cardiovascular diseases, diabetes, Alzheimer’s, Parkinson’s, autism and other ailments. Our instruments, software and sample preparation solutions help scientists conduct faster, more accurate research.

AGILENT RESEARCH LABORATORIES

The purpose of Agilent Research Laboratories is to power Agilent’s growth through breakthrough science and technology.

To complement our product line R&D, Agilent Labs looks beyond the evolution of current products and platforms to create the technologies that will underlie tomorrow’s breakthroughs, enabling Agilent customers to answer questions at the leading edge of life science, diagnostics and the applied markets. Our horizon is broad, encompassing synergies across Agilent and seeding new businesses to create competitive differentiation and compelling value for current and future customers and shareholders.

To accomplish these goals, we attract and retain top technical talent, collaborate extensively with global research leaders in academia, government and industry, and promote a culture of innovation and teamwork across our highly multi-disciplinary staff of life scientists, physical scientists and engineers. The majority of our research is located in the United States in Santa Clara, California, with additional locations in Europe and Asia.