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¿Ü±¹°è Á¦¾àȸ»ç |
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¸ðÁýºÎ¹® |
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CRA |
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- Works in close collaboration with the Medical Affairs Group, Clinical
Project Manager and/or Medical Affairs Manager to ensure preparation,
conduct and closedown of clinical trials
- Support, Manage and Monitor local and global clinical trials in accordance
with all relevant processes, procedures and applicable regulations, ensuring
delivery of data within the agreed parameters (quality/time)
- Prepare for the study initiation : submit applications to the KFDA & IRBs
and get approvals in accordance with the local regulations
- Conduct the site management in accordance with the SOPs, ICH-GCP guidelines
and local regulations from study start up to study close down : contract
management, site initiation, monitoring, investigator¡¯s meeting, data management,
query resolution, AE & SAE reporting, treatment unit management, close out visit etc |
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- Relevant qualification in a life science, pharmacy, nursing or medical sciences
- At least 1 years of experience as CRA in clinical research field and pharmaceutical
industry is preferred
- Good knowledge of SOPs/guidelines, ICH-GCP and other applicable local and international
regulations
- Good communication skills (Korean and English) ; good interpersonal skills
- Proficient in MS Office, including Word, Excel and PowerPoint |
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~ 12. 8 . 19 ±îÁö |
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1Â÷ ¼·ùÀüÇü 2Â÷ ¸éÁ¢ |
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02-597-1780 |
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[Á¢¼ö¹æ¹ý] E-mail : jiko01@kohuman.com (À̸ÞÀÏ Á¢¼ö¸¸ °¡´É) |
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¿Ü±¹°è Á¦¾àȸ»ç |
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