Clinical Research Associate 1 or 2
7 days ago
We are seeking a highly skilled Clinical Research Associate 1 or 2 to join our team at IQVIA in a dedicated FSP role. The ideal candidate will have previous independent on-site monitoring experience and be based in Australia, with the ability to travel interstate.
Key Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits, working closely with sites to adapt, drive, and track subject recruitment plans.
- 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 needed.
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 desirable.
- Ability to travel regularly, including interstate travel.
- Extensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is required.
IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.
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