Covance

  • Senior CRA - Early Clinical Development (home based or office based)

    Job Location(s) ES-Madrid | ES-Barcelona
    Job Number
    2018-18646
    Job Category
    Clinical Research Associate
    Position Type
    Full-Time
  • Job Overview

    Senior CRA position available to work within and international environment across different therapeutics areas and early phases. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Spain. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

    • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets (4 per month)
    • The role can be home based or office based in Madrid.
    • Join a stable team of CRAs and benefit from outstanding training and development, both initially and throughout your career
    • Join a company where people tend to stay for 6-10 years rather than 1-3! 
    • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

    As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:

     

    • All aspects of site management as prescribed in the project plans
    • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
    • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements
    • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.
    • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

    Education / Qualifications

    • University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
    • Thorough knowledge of ICH guidelines, GCP and the clinical trial process
    • Knowledge of the drug development process.
    • Proficient computer skills with good working knowledge of a range of computer packages including Electronic CRF processes.
    • Excellent verbal and written communication skills
    • Valid Driver’s License

    Experience

    • 3-4 years of experience in a related field, including 2-3 years of independent on-site monitoring in CRO or Pharma
    • Experience with Phase I and PoC Studies
    • Strong Oncology experience 

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.