Clinical Research Associate

1 week ago

Sydney, New South Wales, Australia Abbott Full time
The Opportunity

Abbott Medical Australia is seeking a highly skilled Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for monitoring and managing clinical trials in Australia and New Zealand.

Key Responsibilities
  • Assist in the identification and selection of investigators for clinical studies.
  • Collect and maintain regulatory documentation.
  • Participate in investigator meetings and conduct initiation visits, routine monitoring visits, and study close-out visits.
  • Ensure protocol compliance and adherence to relevant regulations, including ICH GCP/ISO 14155.
  • Train site staff as required to meet activation requirements and 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.
  • 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 the preparation of monthly tracking reports for project management.
Requirements
  • 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.
  • 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.
Desirable
  • Proficient in using Microsoft Office Suites (Word, Excel, PowerPoint).
  • Experience in the medical device industry, or combination of medical device and pharmaceutical industry, with a minimum of 12 months monitoring experience.
Competencies and Attributes
  • 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 facilitates 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.

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