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 toundertake clinical studies, when required.Collect and maintain regulatory documentation.Participate in investigator meetings.Conduct initiation visits, routine monitoring visits, and study close-outvisits.Ensure protocol compliance as well as compliance with relevantregulations, including ICH GCP/ISO 14155.Train site staff as required to meet activation requirements and toensure management of non-compliance determined at monitoring visits.Ensure accurate, complete and timely collection of data on case reportforms through source document verification of data.Ensure sites complete data queries in a timely manner.Ensure all Serious Adverse Events are reported, followed up andreconciled against appropriate documentation.Coordinate distribution, tracking and destruction of study supplies persite.Maintain good communication with sites through telephone calls, emailsand correspondence.Liaise with key study personnel at Abbott’s Headquarters and/or country offices as appropriate.Assist in preparation of monthly tracking reports for projectmanagement.Handle and document customer complaints according to Abbott ANZField Event Reporting Standard Operating Procedure.Execute the position and Business Unit responsibilities according toapplicable Abbott ANZ Standard Operating ProceduresPerform other related functions and responsibilities as directed byManager.You may be required to work outside of your ordinary hours of work toparticipate in essential training, team meetings, customer events ortrade shows/conferences. These events may take place on an eveningand/or weekend.Quality, Safety and EnvironmentalAttend regular departmental meetings with relevantmanager/supervisor to build in continuous feedback mechanisms. Meet the requirements of ISO by complying with all relevant Qualitypolicies and procedures to ensure the Quality objectives of the businessare met.Comply with all relevant company Occupational Health, Safety andEnvironmental policies, procedures, and work practices with the intentof preventing or minimising accidental exposures to self, colleaguesand/or the environment.Ensure any PPE provided by the Abbott is worn.Report any accidents or incidents within 24 hours through Donesafe andnotify your manager.ConductEnsure all activities carried out by self and others are in accordance withlegislative employment policies, health & safety requirements and globalpolicy.Promote a standard of excellence for quality and customer focus atAbbott.Uphold the Abbot Code of Business Conduct.Live our Abbott Values – Pioneering, Achieving, Caring, Enduring.Maintain up-to-date knowledge of Abbott standard operatingprocedures and policies and always ensure compliance.Ensure your Company related activities comply with relevant Acts, legaldemands and ethical standards. Qualifications and ExperienceNursing or biological science qualification, or equivalent combination ofeducation and work experience.Preferably greater than 12 months experience in clinical studies workingat 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 otherregulatory guidelines relevant to clinical research in Australia.Knowledge of TGA regulations pertaining to clinical trials and adverseevent reporting requirementsDesirableProficient in using Microsoft Office Suites ie Word, Excel, Powerpoint.Experience in medical device industry, or combination of medical deviceand pharmaceutical industry, with a minimum of 12 months monitoringexperience is preferable. Competencies and AttributesBias 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 resultsThis 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 serveFollow 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.