We are currently seeking a Clinical Research Associate 2 to join our team here at IQVIA. Ideally based in Sydney or Melbourne. Previous independent on site monitoring experience is essential for this role.
Full Australian work rights are required for this role and we can not consider Sponsorship at this time.
**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
- 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