With continuous business growth in Novotech, we are hiring experienced CRAs (CRA II, CRA III, Sr. CRA, Principal CRA)
Brief Position Description:
The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs.
Qualifications & Experience:
- At least 18 months 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
- 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.
(1) 지원 방법
- 제출 서류: 자유형식의 영문이력서 (Word/PDF 형식)
- 지원 방법: 홈페이지 지원
- 인터뷰는 서류검토 합격자에 한해, 지원순서에 따라 순차적으로 진행됩니다.
- 지원서 내용 중 허위사실이 있는 경우 채용이 취소될 수 있으니 신중하게 작성해 주시기 바랍니다.
서류전형->폰 스크리닝->화상 면접->레퍼런스 체크->최종 합격
*유연근무제 실시 (Core time 없는 유연한 근무 지원)
*재택근무 지원금 제공 (home-office set up, Flexible allowance)
*넉넉한 휴가 일수 (연차20일~25일+ 병가10일)
*경조 휴가 및 경조 수당
*명절보너스 (설날/추석) / 생일 상품권 지급
*단체보험 (실비 or 치과보험 포함) / 건강검진
*휴대폰 비용 지원
*Employee Assistance Program(임직원 심리 상담 서비스)
*Recognition Award(동료 칭찬 프로그램 포상)
* 채용 포지션 관련 문의는 Novotech 카카오 채널 채팅방에 남겨주시면 답변 드리겠습니다. (https://pf.kakao.com/_DyxiExj)
-담당자 이메일 : firstname.lastname@example.org
-근무지: 서울시 강남구 테헤란로 87길 22 도심공항터미널 4층 / 서울 강남구 테헤란로 124, 삼원타워 20층
-진행단계에 대한 안내 및 전형결과는 등록하신 이메일로 개별 안내 드립니다.