• Senior CRA - Germany

    Job Location(s) DE-Munich
    Job Number
    Job Category
    Clinical Research Associate
    Position Type
  • Job Overview

    Covance is currently looking for a SCRA to be based in Germany as a home based employee. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

    Education / Qualifications

    Life science degree


    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 of document review
    • Monitor data for missing or implausible data
    • Ensure the resources of the Sponsor and Covance are spent wisely by performing required monitoring tasks in an efficient manner, according to SOPs and established
    • guidelines, including managing travel expenses in an economical fashion according to Covance travel policy (travel, including air travel, may be required and is an essential function of the job).
    • Prepare accurate and timely trip reports and 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 toregulatory authorities, translation of study-related documentation, organization of meetings andother 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
    • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
    • Assist with training, mentoring and development of new employees, e.g. co-monitoring
    • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
    •  Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
    • Excellent understanding of Serious Adverse Event reporting
    • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Germany.
    • Previous experience of leading/managing a CRA team
    • Experience of reviewing CRA trip reports
    • Fluency in speaking and writing both English and German
    • Oncology experience
    • Degree in life sciences OR equivalent experience in clinical monitoring
    • Profound experience in clinical monitoring, oncology experience preferred


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