Lead CRA

  • Permanent contract
  • Paris
  • Full time
Job description

The lead CRA coordinates all aspects of the clinical trial projects in accordance with the company’s interest, regularoty requirements and ICH guidelines.

    Missions

    As part of a project team, he/she will:

    • Participate to the writing of all study’s document (synopsis,  protocole, CRF, safety report, clinical report…),
    • Conduct all types of clinical monitoring visits, e.g. pre-study qualifications, initiations, on site and remote monitoring, and close-out) which includes all preparatory and follow-up aspects.
    • Select and supervise study’s suppliers (logistic,  data management, statistic…),
    • Negotiate study budgets with potential investigators  up to contract signature
    • Take care of the regulatory submission (health authorities, ethical committee…) before and during the study
    • Record the studies in due time in  databases (such as clinicaltrials.gov),
    • Ensure the quality of the trial master file
    Experiences
    • Scientific background with at least 5 years as CRA.
    • Experience in pediatrics and/or in the field of nutrition would be appreciated
    • Fluent English and French,
    • Good communication skills including the ability to obtain information and to convince your interlocutor
    • Methodical, Rigorous and proactive, you like to work in an evolutionary environment.
    Apply
    Upload requirements

    Max file size 3Mo, allowed format: pdf, doc, docx

    Upload requirements

    Max file size 3Mo, allowed format: pdf, doc, docx