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¿Ü±¹°è Á¦¾àȸ»ç Site CRA |
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Site CRA |
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¡Ü Monitors activities conducted by clinical investigative sites as they relate to company clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
¡Ü The SCRA conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring company studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.
¡Ü 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 company Standard Operating Procedures (SOPs) and business processes etc.
¡Ü Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
¡Ü Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
¡Ü Experience in on-site monitoring of investigational drug or device trials is required. |
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¡Ü Bachelor¡¯s Degree required; medical/science/nursing background is preferred.
¡Ü At least 2 years of clinical research monitoring experience.
¡Ü Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
¡Ü Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
¡Ü Experience in on-site monitoring of investigational drug or device trials is required. |
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¡Ü ä¿ëÁ÷±Þ/´ë¸®<br />
¡Ü °æ·Â : 2~6³â<br />
¡Ü À̸ÞÀÏ : jiko01@kohuman.com |
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