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Pharmaceutical Research Associate Professional

2 weeks ago

Sydney, New South Wales, Australia Pharmaceutical Research Associates, Inc Full time

About the Company:

Our client is a leading pharmaceutical research company that is dedicated to advancing new drugs and devices. They are committed to reducing the social and economic burden of disease in society today.

Job Description:

In this exciting role, you will have the opportunity to work with a team of experienced professionals who are passionate about making a difference in the lives of patients.

You will be responsible for supporting the preparation of submission packages (IRB/ERC, regulatory agencies), as well as trial and site administration, including tracking and updating study metrics.

Responsibilities:

  • Setup and maintenance of TMF/eTMF, documents collection and quality check
  • Liaising with clinical sites, as well as internal stakeholders
  • Coordination on drug supply planning, provision and destruction process, trial equipment and materials planning and management
  • Coordination of vendors' activities like printing, translation and other vendors' management
  • Distribution of site materials and equipment
  • Organising meetings

Requirements:

  • Previous clinical trial experience (pharmaceutical or biotechnology industry or investigative site)
  • BS/BA or equivalent preferred
  • Working knowledge of Australian study start-up processes
  • Detail-oriented, passionate and reliable
  • Basic knowledge and understanding of Essential Documents, CFR and GCP/ICH
  • Proficiency with technological systems (Microsoft Office, TMF, CTMS)