[Novotech] CRA (PMS)경력 정규직 채용

노보텍아시아코리아(주)

모집부문 및 자격요건

담당업무	자격요건	인원
** 본 포지션은 PMS 연구를 담당하는 CRA 채용 건 입니다. Responsibilities: CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed. Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required. Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP. Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM. Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP. [근무부서 및 직급/직책] 직급/직책: 사원	Experience and Qualifications * At least 1 year of independent clinical monitoring experience Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level. For Sr. CRA only, the proven experience of capacity to take the Lead CRA role and responsibility Strong communication skill both in written and spoken Korean & English Excellent interpersonal and team collaboration skill with a genuine commitment to contributing to the development of innovative treatment [자격요건] 경력사항: 허가임상경력(2년 이상 ) 학력사항: 대학교(4년)졸업 [우대사항] 전공계열: 의/약학계열	3 명

담당업무

자격요건

인원

** 본 포지션은 PMS 연구를 담당하는 CRA 채용 건 입니다.

Responsibilities:

*CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials.
*In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
*Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required.
*Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
*Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
*Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.

[근무부서 및 직급/직책]

Experience and Qualifications

* At least 1 year of independent clinical monitoring experience
*Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level.

*For Sr. CRA only, the proven experience of capacity to take the Lead CRA role and responsibility

*Strong communication skill both in written and spoken Korean & English

*Excellent interpersonal and team collaboration skill with a genuine commitment to contributing to the development of innovative treatment

[자격요건]

경력사항: 허가임상경력(2년 이상 )
학력사항: 대학교(4년)졸업

[우대사항]

전공계열: 의/약학계열

3 명

근무조건

고용형태: 정규직(수습기간6개월)
급여조건: 연봉 협의 후 결정

전형단계 및 제출서류

전형단계: 서류전형 > 폰스크리닝 > 실무진면접 > 레퍼런스체크 > 최종합격
추가 제출서류
영문이력서(MS-Word 또는 PDF)

접수방법

채용시 마감

접수방법: 자사 홈페이지

기타 유의사항

입사지원서 및 제출서류에 허위사실이 있을 경우 채용이 취소될 수 있습니다.

* 한국에서 CRA로 근무 후 호주로 relocation 한 CRA 분들이 있고 아래 카카오 링크에서 그 분들의 스토리도 보실 수 있습니다. ^^

→ http://pf.kakao.com/_DyxiExj/99465233

→ http://pf.kakao.com/_DyxiExj/99621244