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Clinical Research Associate

2 months ago

Sydney, New South Wales, Australia IQVIA Full time
About the Role

We are seeking a highly skilled and experienced Clinical Research Associate to join our team at IQVIA. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with sites to ensure the quality and integrity of study data.

Key Responsibilities
  • Perform site selection, initiation, monitoring, and close-out visits to ensure compliance with regulatory requirements and study protocols.
  • Provide monitoring visits and site management for a variety of protocols, sites, and therapeutic areas, ensuring that all necessary documentation is complete and accurate.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication to ensure that all sites are aware of their responsibilities and expectations.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations, identifying and addressing any issues or concerns.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans, ensuring that all necessary records are complete and accurate.
  • Collaborate and liaise with study team members for project execution support as appropriate, ensuring that all stakeholders are informed and aligned.
Requirements
  • Bachelor's degree in Life Sciences or other scientific/nursing disciplines.
  • Minimum of 4 years independent site monitoring experience for a Senior Position and minimum of 12 months for other roles.
  • CRO experience is highly desired.
  • Ability to travel on a regular basis, which will involve interstate travel.
  • Extensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
About IQVIA

IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.