존슨앤드존슨
공고
2022년 1월 19일
위치
서울,
카테고리
CRA  
채용 형태

Description

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

1. 포지션: Clinical Research Associate
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular

[Summary]
A CRA serves as the primary contact point between the Sponsor and the Investigational Site. A CRA is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. The Site Manager I will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.

[Responsibilities]
1. Acts as primary local company contact for assigned sites for specific trials.
2. May participate in site feasibility and/or pre-trial site assessment visits
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
7. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies.
10. Ensures site staff complete data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites
12. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs)/Product Quality Complaints(PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
13. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
14. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
15. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
17. Attends regularly scheduled team meetings and trainings.
18. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
19. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
20. Prepares trial sites for close out, conduct final close out visit.
21. Tracks costs at site level and ensure payments are made, if applicable.
22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
24. Acts as a point of contact in site management practices.
25. May contribute to process improvement and training.

[Requirements]
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- A minimum of 2 year of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English. Good written and oral communication.

[지원 기간]
채용시 마감

[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2105980574W검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행

[제출 서류]
영문 자유 양식의 이력서/자기소개서

[유의사항]
1) 온라인 접수를 제외한 지원서 제출은 불가능합니다. (이메일/방문 등)
2) 서류 및 면접 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 일정이 변동될 수 있습니다.
3) 모집 분야와 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다.
4) 제출 서류는 MS-Word 또는 PDF 하나의 파일로 제출하여 주시기 바랍니다.
5) 보훈 대상자 및 장애인은 관련 법률에 의거하여 우대합니다.
6) 허위 기재 사실이 있을 경우 합격이 취소될 수 있습니다.

회사 홈페이지: http://www.careers.jnj.com/
존슨앤드존슨 기업관: https://www.jobkorea.co.kr/Company/1605233/Info

 

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