Medical Research Team Leader
2 days ago
We are seeking an experienced and skilled Senior Clinical Research Associate to perform and coordinate all aspects of the clinical monitoring and site management process.
Key Responsibilities:
- Conducting remote or on-site visits to assess protocol and regulatory compliance and managing required documentation.
- Managing procedures and guidelines from different sponsors and/or monitoring environments.
- Ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability.
Additional Tasks:
- Monitoring investigator sites with a risk-based monitoring approach.
- Ensuring data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
- Assessing investigational product through physical inventory and records review.
Requirements:
- Effective clinical monitoring skills.
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
- Excellent understanding and demonstrated application of ICH GCPs, applicable regulations and procedural documents.
This position requires candidates to currently live in Perth or Adelaide.
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