Clinical Research Associate

at  Abbott Laboratories

Welcome to Abbott! We’re glad you’re here. We create better healthier lives every day at Abbott, and we invite you to be part our journey.

ABOUT US

Abbott 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.
An exciting opportunity has arisen for an enthusiastic and passionate Clinical Research Associate, located in Sydney, for monitoring and study management for Abbott clinical trials in Australia and New Zealand. The Clinical Research Associate (CRA) is the primary contact between the study site staff and Abbott Australia during a trial.

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
  Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.
  In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions for the respective country applicable

• Assist CPL with the identification and selection of investigators to undertake clinical studies, when required.
• Collect and maintain regulatory documentation.
• Participate in investigator meetings.
• 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 14155.
• 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.
• 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.