Clinical Research Associate II – Ukraine

Clinical Research Associate II – Ukraine

Job title: Clinical Research Associate II – Ukraine

Company: Covance

Job description: Job Overview:

Here at Labcorb Drug Development we are currently recruiting for an experienced CRA.

Responsibilities will include:

  • Responsible for all aspects of study site monitoring including routine monitoring andclose-out of clinical sites, maintenance of study files, conduct of pre-study and initiationvisits; liaise with vendors; and other duties, as assigned
  • Ensure the study staff who will conduct the protocol have received the propermaterials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consentprocedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
  • Ensure audit readiness at the site level
  • Travel, including air travel, may be required and is an essential function of the job.
  • Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE

Education/Qualifications:

  • University or college degree, or certification in a related allied health profession from an

appropriately accredited institution (e.g., nursing licensure). An equivalent amount of
experience can be substituted as appropriate.

  • Thorough knowledge of ICH Guidelines and understanding of local regulatory

requirements

  • Thorough knowledge of monitoring procedures
  • Basic understanding of the clinical trial process
  • Valid Driver’s License

Experience:

  • On-site clinical research monitoring experience from 1 year
  • Fluent English and Ukrainian

Expected salary:

Location: Украина

Job date: Wed, 30 Jun 2021 22:27:31 GMT

Apply for the job now!

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