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Clinical Research Associate I, Medical Affairs
Seattle, WA 98109 United States
12-056 & 12-057
NanoString Technologies is a privately held provider of life science tools for translational research and developer of molecular diagnostics. The company’s nCounter® Analysis System is the first and only technology platform to deliver highly multiplexed, direct profiling of individual molecules in a single reaction without amplification. The nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. NanoString is also developing the technology for use in molecular diagnostics.
NanoString currently has openings for 2 Clinical Research Associates in our Medical Affairs group. They will be responsible for monitoring the progress of clinical studies at investigative sites, and ensuring that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The CRA will assist the clinical team in creating, reviewing and preparing documents through the NanoString document control system, maintaining the Trial Master File for each study and filing and preparing any documentation needed for regulatory filings.
Education, training, experience:
• Proven ability to multi-task and work collaboratively as well as independently
• Excellent communication skills (both written and oral)
• Strong attention to detail and superior organizational skills
• Knowledge of GCP guidelines and clinical trial processes
• College degree, preferably in a life science
Additional qualifications include:
• Strong computer skills
• Flexibility with changing priorities
• Previous experience as a Clinical Research Coordinator or Clinical Research Associate is a plus.
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