Clinical Trials Assistant

2 weeks ago

Sydney, New South Wales, Australia Resmed Full time

The Medical Affairs team collaborates with the leaders of Sleep, Respiratory Care, SaaS, ResMed Healthcare, and Asia Growth Markets to ensure our work, especially our clinical research and market access projects, align with their strategic priorities. We also review key government policies, as part of the continuous evaluation and improvement process that helps us maintain global compliance across an ever-shifting landscape of legal and regulatory requirements. The two, research and compliance, work hand-in-hand, and when balanced properly allow us to generate important clinical, economic and market evidence, that improves the lives of patients in ways that are scientifically valid, clinically relevant and ethically sound.

Let's talk about the team:

As a Clinical Trials Assistant, you will be required to support the Clinical Development Specialists and Medical Affairs Management in the clinical development of new products and assist the planning, development, and implementation of clinical trials across the business. This is an individual contributor role.

*This is a 12 month's contract role*

 

Let's talk about the role:

  • Participates in the set-up and implementation of clinical studies through communication between the CDS and the study site.
  • Supports the CDS to ensure that all required devices and materials for the study are prepared and available
  • Ensures the clinical study database and Case Report Forms (CRFs) are prepared in advance of the study commencing
  • Assist in monitoring of the clinical study data during the conduct of the study to ensure compliance to the study protocol and applicable Work Instructions
  • Assists in audits and Regulatory Inspections as required
  • Verifies study documentation files and finalises the study closure reports at the completion of the clinical study
  • Appropriately documents and archives study data and documentation as per Work Instructions following the completion of the clinical study

Let's talk about you:

Required:

  • Bachelor's degree in relevant studies
  • Ability to support multiple clinical studies on relatively tight timelines and prioritise multiple tasks
  • Developing and maintaining relationships with internal and external stakeholders
  • Follows standard practices and procedures and applies basic theories, concepts, principles and methodologies in analyzing situations or data
  • Receives instruction, guidance and direction from others.
  • Proficient in software applications such as Outlook, Word, Excel and PowerPoint

Preferred:

  • Previous experience in the conduct of clinical studies
  • Knowledge of Good Clinical Practice (GCP), ISO 14155, and other guidelines and Standards as appropriate

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now We commit to respond to every applicant.

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