1. 의뢰사: 세계적인 유명 CRO

2. 모집 내용 : Senior / Site Start-Up Specialist 신입 또는 경력 1년이상자 모집

▣ Job Responsibilities(정규직) : 한국 근무 1명 채용 예정

- 임상 시험 경력 1년이상자, 내근직,Study 초반 IRB Submission 담당 예정, 영어 필수
- 임상시험 개시 이전 각 병원 허가 / 계약 등을 담당할 예정!

- Serve as Site Start-Up lead within a country or region for projects or service line. Lead SSU team or service line members in all designated activities. Monitor team efficiency and adherence to project timelines. Ensure adherence to standard operating procedures (SOPs) and work instructions (WIs) and quality of designated deliverables.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Review and provide feedback to management on site performance metrics.
- Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for startup. Review and negotiate regulatory documents, contracts, and contract amendments with sites and sponsors for agreement on wording and budgets. Ensure accuracy and completeness of documents.
- Serve as central contact for investigative sites, designated project reports, and customer service.
- Resolve site issues and determine status for product shipment.

▣ Qualifications Required:
- Bachelor Degree in a related field and 3 years clinical experience for Senior, or 1 years clinical experience for Junior
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Strong knowledge of medical terminology and regulations
- Broad knowledge of clinical research
- Strong knowledge of Microsoft Office and e-mail applications

▣ 연봉수준 및 복리후생: 현, 연봉이상으로 추후 협의 가능/ 주5일제

▣ 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