Clinical Research Director

hace 1 mes

Colombia ICON A tiempo completo

Job Summary

As a Principal CRA at ICON, you will be responsible for managing clinical trials and ensuring the accuracy and completeness of data entered into systems.

You will be working with a pharmaceutical company committed to discovering and developing treatments that improve and save people's lives.

Key Responsibilities

  • Maintain timelines and ensure accuracy and completeness of data entered into systems.
  • Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate.
  • Responsible for the conduct/management of any aspect(s) of a project, when requested and authorised by the respective project manager.
  • Help successfully implement study plans for specific phases of a trial.
  • Slot into existing projects in order to identify potential problems and improve timelines.
  • Co-ordinate and advise others on all the necessary activities required to set up and monitor a study, including:
    • Identify investigators.
    • Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
    • Placement, pre-study and initiation visits.
    • Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate.
    • Complete accurate study status reports.
    • Deal with sponsor generated queries in a timely manner.
    • Ensure the satisfactory close-out of investigator sites.
    • Participate, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.
    • Ensure correct archiving of files on completion of a study.
    • Assume additional responsibilities as directed by the Project Manager.
    • Act in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.
    • Co-ordinate and/or participate in feasibility studies for new proposals, as required.

Requirements

  • Bachelor's degree in a health, life sciences or other relevant field of study.
  • Minimum 8 years' work experience of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company.
  • Availability to travel is required.
  • All employees must read, write and speak fluent English and host country language.

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