Clinical Research Associate (ADX-115-18)

| Greater Boulder Area | Hybrid
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CLINICAL RESEARCH ASSOCIATE / SR. CRA (ADX-115-18)

 

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THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com

 

ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn. 

 

SUMMARY: 

ArcherDX has multiple openings for Clinical Research Associates / Sr. CRAs to join the Companion Diagnostics Program who will be responsible for study coordination and monitoring activities in support of clinical diagnostic studies. 

 

This position will either reside in the Boulder, CO office or remote; both will require travel for site visits domestically and internationally. May travel up to 50%.

 

RESPONSIBILITIES:

  • Coordinate all aspects of study site monitoring, including study file maintenance, according to established plans and procedures
  • Maintain regular communication with site staff, following up on protocol deviations and action items to resolution
  • Prepare accurate and timely reports
  • Act as a contact for shipping and tracking of clinical trial supplies for the sites
  • Responsible for IRB submissions, queries and documentation 
  • Will travel domestically and internationally, up to 50%
  • Review, understanding, and compliance with ArcherDX HIPAA Security policies and procedures
  • Safeguarding the privacy and security of protected health information and European Union personal data
  • Processing and handling of European Union personal data only as directed by ArcherDX for purposes of personalized molecular pathology

 

REQUIREMENTS:

  • BS/BA
  • 3 to 5 years of clinical research experience that includes traveling independently to monitor study data
  • Thorough knowledge of ICH/GCP guidelines is required
  • Knowledge of clinical laboratory operations is a plus
  • Medical tech and/or sample bank experience helpful
  • Experience with oncology and/or medical diagnostic trials a plus
  • Clinical research certification (CCRA, ACRP or equivalent) is a plus
  • Experience with IVD clinical studies is a plus
  • Experience working with Contract Research Labs is a plus
  • Excellent organization skills and attention to detail
  • Ability to work independently in a fast paced and dynamic environment
  • Ability to work cooperatively as a contributing team member, with individuals from diverse backgrounds
  • Strong oral and written communication skills
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Ability to travel domestically and internationally, up to 50%

 

 

 

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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