0000087900-CRA (Oncology - Leukemia)
The Regional CRA conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and company Standard Operating Procedures (SOPs) and business processes. The Regional CRA conducts all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
* Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues
* Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives
* Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel
* Ensure safety and protection of study subjects according to the monitoring plan, company SOPs, ICH Guidelines, and federal regulations
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