1. 의뢰사: 외자 CRO

2. 모집 내용 : 외자, Medical Affairs 경력 3년이상인자 모집

- 대졸이상, 석사 출신 우대
- 의학,약학,간호학,생명공학,수의학 등 관련 학과 우대
- 남녀무관
- 프로토콜 작성 3회 이상, CSR 작성 2회 이상 경험자
- 국내 제약사 임상팀 경력자 우대
- 임상 시험 계획서 작성 경험자 필수
- 관련 경력 3년 이상자

* List of Job role(s) : Protocol development/Supplement of IRB or KFDA/Communication with PI, Sponsor Biostatician, KFDA reviewer

* Responsibilities :
- Project preparation and planning
- General administration
- Project team meeting with Sponsor
- Regular (monthly) report and communication with sponsor
- Site issue handling/ Investigator communication including Newsletter
- Protocol Design
- Informed consent review
- Select study sites/investigators
- Negotiate investigator grants
- Discuss grant payments and contract with sites
- Conduct site qualification visits
- Preparation & Submission to IRB committee
- Respond the question raised by IRBs for Study Protocol
- Submission to regulatory authorities (KFDA)
- Respond the question raised by KFDA for Study Protocol
- Follow-up and communication with Sponsor
- Clinical Study Report Development
- Review and approve integrated study report
- Finalize the Clinical Study Report
- Preparation & Submission of CSR to IRB committee
- Respond the question raised by IRBs for Study Report
- Submission to regulatory authorities (KFDA)
- Respond the question raised by KFDA for Study Report
- Follow-up and communication with Sponsor

▣ 연봉수준 및 복리후생: 현, 연봉 이상 추후 경력에 따라 협의 가능

▣ 근무지 : 서울

▣ 제출서류: 국,영문 이력서 및 상세 경력기술서와 자기 소개서

▣ 진행절차 : 1차 서류 전형- 2차 면접전형

▣ 담당자: 곽지혜
연락처 : 02-567-7407,7408
이메일 : yskim@jhhr.co.kr