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Clinical Research Associate

1 month ago

Sydney, New South Wales, Australia Abbott Full time
The Opportunity

Join Abbott Medical Australia in a challenging role that will see you working on clinical trials in Australia and New Zealand. As a Clinical Research Associate, you will be the primary contact between the study site staff and Abbott Australia during a trial.

Key Responsibilities
  • Assist in the identification and selection of investigators to undertake clinical studies, when required.
  • 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. These events may take place on an evening and/or weekend.
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 always ensure compliance.
  • Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards.
Qualifications and Experience
  • Nursing or biological science qualification, or equivalent combination of education and work experience.
  • Preferably greater than 12 months experience in clinical studies working at a high level of competency. Cath lab or cardiovascular disease experience would be an advantage.
  • 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
Desirable
  • Proficient in using Microsoft Office Suites ie Word, Excel, Powerpoint.
  • Experience in medical device industry, or combination of medical device and pharmaceutical industry, with a minimum of 12 months monitoring experience is preferable.