Senior CRA / CRA /Assistant CRA / 外資製薬メーカー
|職種||Senior CRA / CRA /Assistant CRA|
・Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
・The Senior Site Clinical Research Associate (Sr. SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas， ensuring AbbVie studies are conducted according to all applicable regulations and business processes.
・Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e.， greater number of sites， site participating in more complex clinical studies， sites requiring more oversight of operational issues).
・Additionally， the Sr. SCRA may train and provide guidance to junior staff.
・Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
・Conducts site qualification， initiation， interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations， Good Clinical Practices (GCPs)， ICH Guidelines， and AbbVie Standard Operating Procedures (SOPs) and business processes.
・Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
・Manages and monitors the activities of clinical investigative sites across a maximum of 5 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， than those assigned to SCRAs.
・Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
・Is proactive in managing the site and ensures action plans are put in place as needed to ensure compliance.
・Ensures quality of data submitted from study sites and assures timely submission of data， including appropriate reporting and follow-up for all safety events by site personnel.
・Ensures safety and protection of study subjects through compliance with the study monitoring plan， AbbVie SOPs， ICH Guidelines， and applicable regulations.
・Trains study site personnel on the protocol and applicable regulatory requirements in collaboration w
|求める経験||・Minimum of 3 years of clinical related experience， with a minimum of 2 years as clinical research monitor.
・Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Excellent knowledge of regulations governing clinical research， ICH/GCP Guidelines and applicable regulations.
・Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
|年収||600万円 - 1000万円|