1. Support, manage and monitor local and global clinical trials studies in accordance with all relevant processes and procedures & applicable clinical research regulations, ensuring delivery of data within the agreed parameters(quality/time)
2. Prepare for the study initiation with clinical project manager : submit applications to the KFDA & IRBs and get approvals in accordance with the local regulations
3. Conduct the site management in accordance with the SOPs, ICH, GCP guidelines from study start up to study close down : monitoring, CRF review, investigator meeting, data management, query resolution, AE & SAE reporting, treatment unit supply
4. Provide monitoring reports and appropriate information to clinical project leader using local and central tracking systems within required timelines. Make study files available for audit by quality assurance and/or inspection by Korean Regulatory Authorities
5. Maintain appropriate communication with the key internal and external parties
경력 및 자격요건
1. Pharmacist or nurse or major in scientific field is preferred
2. At least 2years of experience as CRA in clinical research field and pharmaceutical industry is preferred
3. Good knowledge of regulatory environment for clinical trials
4. Good communication skills(Korean and English) ; good interpersonal skills
기타
- 원서 마감후 1차(서류) 합격자에 한하여 개별연락
- 이력서에 연락처, 희망연봉 게재
- 해외여행에 결격 사유가 없는 자
담당업무
입사지원
돌아가기
02-6281-5045
cwlim@nterway.com
