About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were 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. 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 ideally works out of Melbourne or Perth, though Sydney applicants are welcome. As the Clinical Research Associate / Senior Clinical Research Associate, youll be 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. What Youll Do Assist Clinical Project Lead (CPL) with the identification and selection of investigators to undertake clinical studies, when required. Collect and maintain regulatory documentation and 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 all serious Adverse Events are reported, followed up and reconciled against appropriate documentation. Coordinate distribution, tracking and destruction of study supplies per site. Liaise with key study personnel at Abbotts Headquarters and/or country offices as appropriate. Assist in preparation of monthly tracking reports for project management. Required Qualifications and experience Nursing or biological science qualification, or equivalent combination of education and work experience. Good working knowledge of ICH GCP/ISO 14155 guidelines and knowledge of TGA regulations pertaining to clinical trials Preferred Qualifications and Experience Experience in medical device industry, or combination of medical device and pharmaceutical industry, with a minimum of 12 months monitoring experience is preferable. Preferably greater than 12 months experience in clinical studies and/or cath lab or cardiovascular disease experience would be an advantage. Proficient in using Microsoft Office Suites The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Research and Discovery DIVISION: MD Medical Devices LOCATION: Australia : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable #J-18808-Ljbffr
Job Title
Clinical Research Associate