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Job

Informed Consent Review Specialist

  • Location

    Remote

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Contact:

    Charlie Mills-Swanscott

  • Contact email:

    charliemills-swanscott@hotmail.co.uk

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    CM1

  • Published:

    about 1 month ago

  • Duration:

    Initially 3 Months

  • Expiry date:

    2021-04-09

  • Startdate:

    ASAP

A leading life science company requires a Informed Consent Review Specialist to join their business, offering a fully remote opportunity (you can be based across Europe), the role is an inital 3 Months contract with potential for extension.

Responsibilities:

  • As the Informed Consent review specialist you will be responsible for TMF reconciliation, Quality Check and Discrepancy Documentation
  • As the Informed Consent Review specialist you will Read and review Informed Consent Forms - ICF (globally) and  complete ICF Tracking / Attribute Log
  • Ensure compliance and inspection readiness of Phase I-IV clinical trials

Experience:

  • Experienced in clinical research for at least 1-2 years as CTA; CRA or study start-up specialist, preferably
  • Extensive experience in eTMF systems and Informed Consent creation / review
  • Has clear Knowledge and experience in ICH-GCP regulation, other relevant guidance documents (e.g. FDA, EMA) and requirements of Informed Consent in major countries
  • Experienced in related systems and databases such as CTMS; EDC would be a plus

If you are interested in learning more about the role you can reach me via email @ c.mills-swanscott@hamlynwilliams.com or via telephone +44 203 545 1110

I look forward to hearing from you,

#LI-CM5