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Clinical Research Associate

2 months ago

Australia Abbott Laboratories Full time

About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Job Summary

We are seeking an enthusiastic and passionate Clinical Research Associate to join our team in Sydney. As a Clinical Research Associate, you will be the primary contact between the study site staff and Abbott Australia during a trial. Your responsibilities will include:

  • Study Site Management
    • Assist in the identification and selection of investigators to undertake clinical studies.
    • Collect and maintain regulatory documentation.
    • Participate in investigator meetings.
  • Monitoring and Study Management
    • Conduct site assessment and initiation visits, routine monitoring visits, and study close-out visits.
    • Ensure protocol compliance as well as compliance with relevant regulations, including ICH GCP/ISO.
    • Ensure accurate, complete and timely collection of data on case report forms through source document verification of data.
  • Regulatory Compliance
    • Ensure sites complete data queries in a timely manner.
    • Ensure all Serious Adverse Events are reported, followed up and reconciled against appropriate documentation.
    • Coordinate distribution, tracking and destruction of study supplies per site.
  • Communication and Collaboration
    • Maintain good communication with sites through telephone calls, emails and correspondence.
    • Liaise with key study personnel at Abbott's Headquarters and/or country offices as appropriate.
  • Reporting and Administration
    • Assist in the preparation of monthly tracking reports for project management.
    • Handle and document customer complaints according to Abbott ANZ Field Event Reporting Standard Operating Procedure.

Requirements

To be successful in this role, you will need:

  • A nursing or biological science qualification, or an equivalent combination of education and work experience.
  • Preferably greater than 12 months experience in clinical studies working at a high level of competency.
  • A good working knowledge of ICH GCP/ISO 14155 guidelines and other regulatory guidelines relevant to clinical research in Australia.
  • Knowledge of TGA regulations pertaining to clinical trials and adverse event reporting requirements.

What We Offer

Abbott Laboratories is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.