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Clinical Research Associate 2
2 weeks ago
We are currently seeking a Clinical Research Associate 2 to join our dedicated Sponsor team here at IQVIA. Ideally based in Sydney or Melbourne. Previous independent on site monitoring experience is essential for this role.
**Key Responsibilities**
- Provide monitoring visits and site management for a variety of 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 enrolment, 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.
**Not everyone can be a CRA it’s an extraordinary role, do you meet this unique criteria?**
- Bachelor's degree in Life Sciences or other scientific/nursing disciplines is essential
- Minimum of 2 years independent site monitoring experience for a CRA 2, and a minimum of 4 years independent site monitoring experience for a Sr CRA 1
- 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
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