- Entry level
- No Education
- Salary to negotiate
JOB DESCRIPTION: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 103,000 colleagues serve people in more than 160 countries.
An excellent opportunity for an experience Clinical Research Associate to monitor and coordinate study management for clinical trial programs and projects within the country.
In this position you shall be the contact between study site staff during the trial period. You shall be responsible for:
- Assist CPL with the identification and selection of investigators to undertake clinical studies, when required
- Prepare documentation for Ethics Committee submissions
- 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
- according to SJM Standard Operating Procedures (SOPs) and Regulatory guidelines
- Assist the CPL to ensure payments are tracked, on time and within budget
- 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 SJM’s Headquarters and/or country offices as appropriate
- Assist in preparation of monthly tracking reports for project management.
- Have a sound understanding of, and comply with, the industry (MTAA) the SJM Code of Conduct and
- Company Compliance requirements
- Handle and document customer complaints according to SJM ANZ Field Event Reporting Standard Operating
- Knowledge of and commitment to the requirements of the Quality Management System.
- Knowledge of and commitment to Work, Health & Safety responsibilities.
- Action any other customer complaints with relevant SJM ANZ Business Unit.
- Execute the position and Business Unit responsibilities according to applicable SJM ANZ Standard Operating
- Perform other related functions and responsibilities as directed by Manager
Professional Knowledge, Skills & Qualifications
- 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.
- Experience in medical device industry, or combination of medical device and pharmaceutical industry, with a
- minimum of 12 months monitoring experience is preferable.
- Knowledge of TGA regulations pertaining to clinical trials and adverse event reporting requirements
- 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 co-ordinates 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.
- Proficient in using Microsoft Office Suites ie Word, Excel, Powerpoint
- Nursing or biological science qualification, or equivalent combination of education and work experience
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.
Abbott provides some fantastic benefits for our employees, these include:
- Free parking on site
- Discounted Healthcare
- Discounted Shares program
- Salary Sacrifice Options
- AND…..Lots, lots more
To apply for this exciting opportunity, please visit our careers site at www.abbottcareers.com for more information
Abbott is an equal opportunity employer
We ask that recruiters respect our internal recruitment process and PSA panel, and refrain from contacting us, or referring candidates to this role.
Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
JOB FAMILY:Research and Discovery
DIVISION:MD Medical Devices
LOCATION:Australia Macquarie Park : 299 Lane Cove Road
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
About the company
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.