Covance Sr Clinical Research Associate, Netherlands in Amsterdam, Netherlands

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; liaise with vendors; and other duties, as assigned

  • Responsible for all aspects of site 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

  • Manage small projects under direction of a Project Manager/Director as assigned

  • Serve as lead monitor for a protocol or project, and may assist in establishing monitoring plans and trip report review as assigned

  • Review progress of projects and initiate appropriate actions to achieve target objectives

  • Organize and make presentations at Investigator Meetings

  • Participate in the development of protocols and Case Report Forms as assigned

  • Participate in writing clinical trial reports as assigned

  • Interact with internal work groups to evaluate needs, resources and timelines

  • Act as contact for clinical trial supplies and other suppliers (vendors) as assigned

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

  • Undertake feasibility work when requested

  • Conduct, report and follow-up on Quality Control Visits (CQC) when requested

  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned

  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned

  • Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs

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 2018-20531

Job Category Clinical Research Associate

Position Type Full-Time

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