臨床開発モニター / CRA : 大手外資系製薬メーカー (600～800万円）仕事No. 42628-13
Primary Goals/ Objectives
- Monitors activities conducted by clinical investigative sites as they relate to the company's clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
- The Site Clinical Research Associate (SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.
Major Duties and Responsibilities
- 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 the company's 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.
- 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, company SOPs, ICH Guidelines, and applicable regulations.
- -Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in clinical research monitoring.
-Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
-Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
-Experience in on-site monitoring of investigational drug or device trials is required.
- TOEIC 700
- 年収600 ～ 800万円
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