CRA II - Russia
Labcorp Drug Development
St. Petersburg, Russia
5 дней назад

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
  • Preferred :

  • Thorough knowledge of Company SOPs regarding site monitoring
  • Experience : Minimum Required :

    Minimum Required :

  • A minimum of 1 (One) year of Clinical Monitoring experience is preferred, or an
  • equivalent combination of education and experience to successfully perform the key

    responsibilities of the job can be substituted.

  • Ability to monitor study sites independently according to protocol monitoring
  • guidelines, SOP, and local regulatory Guidelines

  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process
  • production of reports, narratives and follow up of SAEs

  • Good planning, organization and problem- solving abilities
  • Ability to work with minimal supervision
  • Good communication and interpersonal skills
  • Good analytical and negotiation skills
  • Computer competency
  • Fluent in local office language and in English, both written and verbal
  • Works efficiently and effectively in a matrix environment
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