*채용기관명: 한국MSD (http://msd-korea.com)
직무 : (Sr.)CRA
인원 : 6명(증원에 따른 채용)
Acts as primary site contact and site manager throughout all
phases of a clinical research study, taking overall responsibility of allocated
•Develops strong site relationships and ensures continuity of site
relationships through all phases of the trial.
•Performs clinical study site management/monitoring activities in compliance
with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site
Monitoring Plan and associated documents.
•Gains an in-depth understanding of the study protocol and related
•Coordinates & manages various tasks in collaboration with other sponsor
roles to achieve Site Ready.
•Participates & provides inputs on site selection and validation
•Performs remote and on-site monitoring & oversight activities using
various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o Subjects’ right, safety and well-being are protected
•Conducts site visits including but not limited to validation visits,
initiation visits, monitoring visits, close-out visits and records clear,
comprehensive and accurate visit & non-visit contact reports appropriately
in a timely manner.
•Collects, reviews, and monitors required regulatory documentation for study
start-up, study maintenance and study close-out.
•Communicates with Investigators and site staff on issues related to protocol
recruitment, retention, protocol deviations, regulatory documentation, site
audits/inspections and overall site performance.
•Identifies, assesses and resolves site performance, quality or compliance
problems and escalates per defined CRA Escalation Pathway as appropriate in
collaboration with CRM, PLM and RCPM.
•Manages and maintains information and documentation in CTMS, eTMF and various
other systems as appropriate and per timelines.
•Contributes to CRA team knowledge by acting as process Subject Matter Expert
(SME), buddy/mentor and sharing best practices as appropriate/required.
•Supports and/or leads audit/inspection activities as needed
조건: global study,
Oncology monitoring 경력
조건: CRO 혹은
제약회사에서 CRA 경력이
형태 : 정규직
요일/시간: 월 – 금, 오전
- 급여 : 면접 후 협의
시작일 : 2019년 9월~11월
- 복리후생 : 4대보험,
퇴직금, 인센티브, 연차, Live it days(휴가), 건강검진, 자녀학자금
접종, Family day, 주 1회
지원, 식대보조비, 출퇴근보조비, 단체생명보험, 각
방법 : https://msd.wd5.myworkdayjobs.com/SearchJobs/job/KOR---Seoul---Seoul-Square/CRA_R4164 에
절차 : 서류
전형 - 부서
실무면접 - 온라인
검사 - 신원조회 - 근로계약
기한 : 채용 마감 시 까지
연락처 : 인사부 최민정(firstname.lastname@example.org)
- pdf 혹은 word 파일로