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Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical
Ensures adherence to federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie
Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4
Overviews site personnel activities and motivates/influences them to meet study objectives
Ensures quality and timely submission of data from study sites, including safety event reporting
Ensures safety and protection of study subjects through compliance with monitoring plan and

Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred
Minimum 1 year clinically related experience, with 6 months in clinical research monitoring
Experience in on-site monitoring of investigational drug or device trials required
In-depth knowledge of therapeutic indications relevant to clinical trials
In-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines
Strong planning and organizational skills

Clinical Research Associate I

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