Covance Clinical Research Associate I, Russia in Moscow, Russia

Job Overview

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance; liaise with vendors; and other duties, as assigned

  • Responsible for aspects of registry management as prescribed in the project plans

  • General On-Site Monitoring Responsibilities:Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

  • Ensure the protection of study patients by verifying that informed consent procedures 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

  • Monitor data for missing or implausible data

  • Ensure the resources of the Sponsor and Covance are spent wisely by performing theguidelines, including managing travel expenses in an economical fashion according to Covance travel policy

  • required monitoring tasks in an efficient manner, according to SOPs and established

  • Travel, including air travel, may be required and is an essential function of the job.

  • Prepare accurate and timely trip reports

  • Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Covance or client data management systems, as assigned by management

  • Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management

  • Provide coverage for clinical contact telephone lines, as required

  • Update, track and maintain study-specific trial management tools/systems

  • Generate and track drug shipments and supplies, as needed

  • Track and follow-up on serious adverse events as assigned

  • Implement study-specific communication plan as assigned

  • Attend investigators’ meetings, project team meetings and teleconferences, as needed

  • Assist Senior CRA in managing investigator site budgets

  • Perform other duties as assigned by management

Education / Qualifications

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

  • a minimum of 2 years of experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)

Experience

  • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, ICH Guidelines and GCP

  • Ability to work within a project team

  • Good planning, organization and problem solving abilities

  • Good communication skills, oral and written

  • Good computer skills

  • Works efficiently and effectively in a matrix environment

  • Fluent in local office language and in English, both written and verbal

Job Number 2018-21591

Job Category Clinical Research Associate

Position Type Full-Time

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