Clinical Research Associate

2 weeks ago

Sydney, New South Wales, Australia Abbott Full time

The Opportunity

This position works for Abbott Medical Australia, a leading medical device company that helps thousands of people worldwide. Our medical devices improve quality of life for people living with chronic pain and movement disorders, and liberate people with diabetes from routine fingersticks.

Reporting to the Clinical Operations Manager, this position is responsible for monitoring and study management for Abbott clinical trials in Australia and New Zealand.

  • Assist in the identification and selection of investigators to undertake clinical studies.
  • Collect and maintain regulatory documentation.
  • Participate in investigator meetings.
  • Conduct initiation visits, routine monitoring visits, and study close-out visits.
  • Ensure protocol compliance as well as compliance with relevant regulations, including ICH GCP/ISO 14155.
  • Train site staff as required to meet activation requirements and to ensure management of non-compliance determined at monitoring visits.
  • Ensure accurate, complete and timely collection of data on case report forms through source document verification of data.
  • 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.
  • 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.
  • Assist in preparation of monthly tracking reports for project management.
  • Handle and document customer complaints according to Abbott ANZ Field Event Reporting Standard Operating Procedure.
  • Execute the position and Business Unit responsibilities according to applicable Abbott ANZ Standard Operating Procedures.
  • Perform other related functions and responsibilities as directed by Manager.
  • You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences.

Quality, Safety and Environmental

  • Attend regular departmental meetings with relevant manager/supervisor to build in continuous feedback mechanisms.
  • Meet the requirements of ISO by complying with all relevant Quality policies and procedures to ensure the Quality objectives of the business are met.
  • Comply with all relevant company Occupational Health, Safety and Environmental policies, procedures, and work practices with the intent of preventing or minimising accidental exposures to self, colleagues and/or the environment.
  • Ensure any PPE provided by the Abbott is worn.
  • Report any accidents or incidents within 24 hours through Donesafe and notify your manager.

Conduct

  • Ensure all activities carried out by self and others are in accordance with legislative employment policies, health & safety requirements and global policy.
  • Promote a standard of excellence for quality and customer focus at Abbott.
  • Uphold the Abbot Code of Business Conduct.
  • Live our Abbott Values – Pioneering, Achieving, Caring, Enduring.
  • Maintain up-to-date knowledge of Abbott standard operating procedures and policies and always ensure compliance.
  • Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards.

This role will work within a team of very capable and passionate individuals committed to getting the best outcomes for the patients and the customers that we serve.

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