Clinical Research Associate/Clinical Scientist- New Jersey (ADX-210-19)

7 days left

Recruiter
ArcherDX
Location
Newark, New Jersey
Posted
Nov 07, 2019
Closes
Nov 21, 2019
Ref
c6fd5ad448d0
Sector
Science
Organization Type
Corporate
COMPANY OVERVIEW:

ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion, and grit to meet these goals.

Make it happen by joining us in the fight against cancer.

SUMMARY:

Residing in New Jersey, the Clinical Research Associate / Clinical Scientist will join our Companion Diagnostics Program. They will be responsible for study coordination and monitoring activities in support of clinical diagnostic studies. This position requires 50% onsite presence at CRO/Clinical Lab. Travel as needed - both international and domestic.

RESPONSIBILITIES:
  • Coordinate all aspects of study site monitoring, including study file maintenance, according to established plans and procedures
  • Maintain regular communication with CRO staff, following up on protocol deviations to resolution
  • Prepare accurate and timely trip reports, and deviation summary reports for the project core team
  • Act as a contact for shipping and tracking of clinical trial supplies for the CRO sites
  • Assist sites with site-level IRB submissions, queries and documentation
  • Travel is required domestically and internationally, up to 35%
  • Other duties as assigned
  • 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.

EXPERIENCE:
  • BA/BA degree
  • 3 to 5 years of clinical research experience that includes traveling independently to monitor study data.
  • Clinical research certification (CCRA, ACRP or equivalent) is preferred.
  • Thorough knowledge of ICH/GCP guidelines is required.
  • 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
  • Next-Generation Sequencing and/or other diagnostic laboratory experience is a plus
  • Knowledge of clinical laboratory operations is a plus
  • Med-tech and/or sample bank experience is a plus

KEY ATTRIBUTES:
  • Drive and determination
  • Ability to work in a fast-paced and dynamic environment
  • 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.
  • Strong communication and presentation skills
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction
    • Able to organize, prioritize, and delegate tasks to efficiently move projects forward.

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