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Nanosphere Inc

 Nanosphere develops, manufactures and markets an advanced molecular diagnostic platform, the Verigene System, which enables simple, cost-effective, and highly sensitive nucleic acid (DNA and RNA) and protein testing on a single platform.Our breakthrough technology helps hospitals improve patient care and lowers costs by providing time-critical information, allowing earlier detection of disease and more targeted treatment.  Our products have the potential to:    * Empower physicians to better... Read More

Address      Nanosphere, Inc. 4088 Commercial Ave Northbrook, IL 60062
Website      www.nanosphere.us/
Holding      No Holding Details

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Clinical Research Associate

Primary responsibility is 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.

Additional responsibilities include:

    * Set-up, monitoring and close-out of clinical studies at investigative sites
    * On-site visits to assess the qualification of potential investigative sites, train on protocol and product, initiate studies, instruct site personnel on the proper conduct of studies, review data and ensure accuracy of data collected
    * Liaison with investigators and study personnel
    * Provide regular clinical status information to team members and cross-functional representatives
    * Work closely with other team members to ensure timely resolution of project and/or clinical issues
    * Perform source document verification, retrieve case report forms (CRFs) and perform query resolution in a timely manner
    * Oversee investigational material accountability and safety at investigative sites
    * Ensure Serious Adverse Event (SAE) reporting according to SOPs
    * Respond to requests from investigative sites in a timely fashion
    * Assist in development, review and writing of study protocols, CRFs and reports
    * Writing, filing and collating study documentation including all site correspondence

Experience and Qualifications

    * Undergraduate degree in a clinical, scientific, or related field
    * An advanced degree (e.g., M.S., M.B.A., PharmD, etc) preferred
    * Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail
    * Excellent communication skills (both written and oral)
    * Ability to build effective relationships with study site staff and colleagues
    * High multi-tasking capabilities and good organizational skills
    * Can-do attitude with a willingness to go the extra mile to assure project success.

In-House or Field-Based position—extensive travel required within U.S. and possible international travel

Other Job Information

Vacancy type:

Full Time

Contact Mode:



not provided

Contact Name:

not provided

Job Duration:

not provided





TalentOne Job Information

Healthcare Clinical Research Project Manager

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