[담당업무]
• ICH-GCP Guidelines에 근거하여 국내외 임상 1상~3상 진행(feasibility, Site initiation visit, co-monitoring, IRB etc)
• 국내외(식품의약품안전처/FDA) 의약품의인허가 등록서류 작성, 검토, 관리 및 제출 등
• 국내외 CRO 관리
• 임상시험 및 RA 인허가 관련한 SOP 개정/제정 등

• Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in local/global phase I-III ensuring that applicable regulations and principles of ICH-GCP are adhered to.
• Working independently and proactivity to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation.
• Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested etc.
• Managing the local/global CRO.
• Establish/Modified SOP related with clinical trial and RA.
• To prepare/submit the IND documents in KFDA/FDA etc.
 
[자격요건]
• 관련학과(약학, 간호학, 생명공학 등) 학사 이상
• CRA 혹은 RA(Regulatory Affairs) 최소 1년 이상 경험자 (IND 제출 경력자 우대)
• Good English communication skill
• ICH GCP Guidelines에 대한 이해도가 높은 분

[근무장소]
대전(숙소제공)

*복리후생: 4대보험, 경조금, 중식∙석식제공, 연차, 퇴직금, 야근∙휴일수당, 주차비 지원, 건강검진