[회사소개]https://www.msd-korea.com/

글로벌 헬스케어 기업인 한국MSD는 1994년 설립된 이후 우수의약품과 전문 의학정보를 제공해왔습니다. 건강한 세계를 만들고자 노력하는 기업비전을 실현하며 한국인의 질병치료와 건강증진을 위해 꾸준히 노력하고있습니다. 또한 The Fortune지가선정한 미국에서 "가장 존경받는 기업"으로 11년 연속수상한 바 있는 세계적인 기업입니다.

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-다양한 Pipeline을 가진 미국 제약회사로 성장 가능성이 큰 회사입니다.

-Oncology, Global study 를 하시며 Career development 할 수 있습니다.

-Full 재택 근무 가능합니다.(수습기간 종료 후)

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[HR Talk]

한국 MSD의 임상부서인 GCTO팀에서 (Sr.) CRA로 근무해주실분을 다수 모집합니다.

지원자격은 Global monitoring 경력이 있으신 분(Oncology study 선호)입니다. (최소 2년 이상의 모니터링 경력 요구)관련하여 궁금한 점이 있으신 분들께서는 kr_recruit@merck.com으로 문의 주십시오. 지원 방법은 하단의 내용 확인 부탁드립니다.

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[업무내용]

Acts as primary site contact and site manager throughout all phases of a clinical research study,taking overall responsibility of allocated sites.

•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 procedures.

•Coordinates& manages various tasks in collaboration with other sponsor roles to achieve Site Ready.

•Participates& provides inputs on site selection and validation activities.

•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 conduct,

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 systemsas 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

Competency Expectations:

•Fluent in Local Languages and English (verbal and written) and excellent communication skills,including the ability to understand and present technical information effectively.

•Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.

•Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.

•Hands on knowledge of Good Documentation Practices

•Proven Skills in Site Management including management of site performance and patient recruitment

•Demonstrated high level of monitoring skill with independent professional judgment.

•Good IT skills(Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.

•Ability to understand and analyze data/metrics and act appropriately

Behavioral Competency Expectations:

•Effective time management, organizational and interpersonal skills, conflict management,problem solving skills

•Able to work highly independently across multiple protocols, sites and therapy areas.

•High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.

•Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.

•Demonstrates commitment to Customer focus.

•Works with high quality and compliance mindset

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[지원자격]

-B.A./B.S. required with strong emphasis in science and/or biology

-Min. 2 years of direct site monitoring experience in a bio/pharma./CRO preferred

[지원방법]

https://msd.wd5.myworkdayjobs.com/SearchJobs/job/KOR---Seoul---Seoul-Square/Clinical-Research-Associate_R57258 에서지원가능

[채용절차]

서류 검토 – 온라인 인적성 검사 - 1차 면접 – 최종 합격

[근무지]

서울시 중구 한강대로 416, 서울스퀘어 23층 MSD 서울사무소

[면접일정]

지원 순서대로 서류 검토

[지원 시 유의사항]

-서류 합격자에 한하여 연락 드리고 있습니다.

-이력서에 개인민감정보는 기재하지 말아주십시오. (주민번호, 가족관계 등)

-지원 시 파일은 하나로 통합하여 PDF 혹은 Word파일로지원부탁드립니다.

-입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.

-기타문의사항은 kr_recruit@merck.com로 문의바랍니다.