Entry level CRA (UK/EU home based) (m/w/d) - Iqvia Biotech
IQVIA
Vienna, AT
vor 4 Tg.
source : DirectEmployers Association

Job Overview Trainee CRA's required to perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, , Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Escalate quality issues as appropriate.

  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensure copies / originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications
  • Bachelor's Degree in scientific discipline or health care preferred.
  • Equivalent combination of education, training and experience may be accepted in lieu of degree.
  • You will need to have completed or be in the process of completing of a CRA training program or haven prior monitoring experience.
  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • If you are applying in the UK, fully fluent in English.
  • If you are applying to a European role you will need to be fluent in the local language and English.
  • Organizational and problem-solving skills.
  • Effective time management skills and ability to work autonomously.
  • Ability to establish and maintain effective working relationships with co-workers, managers, and clients. What we provide Intensive 4-week CRA training, after you have completed this you will start co-monitoring with more experienced CRA's until you are ready to perform sole monitoring activities.
  • At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

    The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

    Melde diesen Job
    checkmark

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Bewerben
    E-Mail
    Klicke auf "Weiter", um unseren Datenschutz-und Nutzungsbestimmungen zuzustimmen . Du kriegst außerdem die besten Jobs als E-Mail-Alert. Los geht's!
    Weiter
    Bewerbungsformular