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Clinical Research Associate

2 months ago

North Sydney Council, Australia IQVIA Argentina Full time
Key Responsibilities

We are seeking a highly skilled Clinical Research Associate to join our team at IQVIA Argentina. The ideal candidate will have previous independent on-site monitoring experience and be able to work with sites to adapt, drive, and track subject recruitment plans.

Key Responsibilities:

  • Perform site selection, initiation, monitoring, and close-out visits.
  • Provide monitoring visits and site management for various protocols, sites, and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • 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.
  • Collaborate and liaise with study team members for project execution support as appropriate.

Requirements:

  • Bachelor's degree in Life Sciences or other scientific/nursing disciplines is essential.
  • Minimum of 1 year independent site monitoring experience is required.
  • 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 is required.