담당업무

ㆍScientific medical supports

   - Develop/revise medical monitoring plan

   - Protocol deviation review including subject eligibility etc.

   - Ensure a response to medical query to be provided

   - Attendance at medical teleconferences and team meeting as appropriate

ㆍReview of clinical data 

   - Medical review of clinical data as per the requirement

   - Data clearing supporting

   - Medical coding review

   - Generate/follow up queries as needed 

   - Manage medical monitoring log and Q&A log 

   - Other responsibilities according to the sponsor requirement

ㆍSupport safety review committee  

   - Develop/revise safety review committee charter 

   - Prepare/lead safety review committee meeting 

   - Draft safety review committee meeting minutes

ㆍArchiving relevant documents 

자격요건

ㆍ약학, 간호학, 생명공학 등 학사 이상의 전공자

ㆍ임상업계 경력(모니터링 포함) 3년 이상 경력자 

ㆍ프로토콜 및 EDC 에 대한 이해도가 높은 자

우대사항

ㆍMS Office 숙련자

ㆍ영어 의사소통 가능자