Clinical Research Associate

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of .
• Amazing health and wellness benefits and perks.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works for the Abbott Medical Australia. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 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. The Clinical Research Associate (CRA) is the primary contact between the study site staff and Abbott Australia during a trial.

• 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 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.

• 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.

• 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.

• 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

• 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.

• Bias for Action / Initiative: Acts on opportunities for solving problems, increase business or meeting objectives before being asked or required to do so.
• Open Communication / Listening: Ensures accurate understanding and acts in a way that facilities open exchange of ideas and information.
• Planning and Organising: Effectively identifies, plans, schedules and coordinates the resources (people, material, information, time) required to accomplish goals.
• Quality Commitment: Demonstrates attention to producing a high quality end product and constantly looks for opportunities to improve work processes and results

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

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.