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 Specialist
2. 계열사: 존슨앤드존슨 메디칼 (MedTech)
3. 근무지: 서울시 용산구
4. 근무 형태: Fixed Term (1 year)
[Responsibilities]
1. Be responsible for assessment and analysis of Clinical Trial proposals (Investigator Initiated Trial / Sponsor Initiated Trial)
2. Participates in site assessments, conducts pre-trial site assessment in collaboration with the trial team. Be responsible for Institutional Review Board submission, budget management and contract negotiation
3. Attends/participates in investigator meetings as needed.
4. Be responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out per internal SOPs, other procedural document and policies.
5. Ensures site staff have current GCP and necessary protocol, compound and systems training to conduct the clinical trial. Complete retraining when needed. Ensure training records are filed at site.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies are adequate for trial conduct.
8. Ensures site staff complete the data entry and resolve queries within expected timelines. Set up plan to improve data entry in collaboration with the trial team.
9. Ensures accuracy, validity and completeness of data collected at trial sites. Ensures appropriate measures are in place for maintenance of the blind when applicable
10. Ensures that all Adverse Events (AE)/Serious Adverse Events (SAE)/Product Quality Complaints (PQC) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
11. Fully documents trial related activities with respect to study monitoring. Writes visit reports and address follow-up letters to investigators within procedural timelines. Responsible for documentation
and escalation of major deviations and issues to appropriate stakeholders. Ensures timely corrective actions are completed and documented.
12. Reviews investigator site File for completeness and ensures archiving retention requirements, always including storage in a secure area.
13. Attends regularly scheduled team meetings and trainings.
14. Prepares trial sites for close out, conduct final close out visit.
15. Maintains collaborative working relationship between APAC medical affairs/clinical research team for global projects
16. Collaborates with Taiwan & Hongkong partners to plan and execute medical affairs activities
17. Collaborates with internal stakeholders (HEMA, RA, GA, etc.) for clinical support with evidence
18. Supporting in assessing Surgical innovation and all 3 franchises – Ethicon, DePuy Synthes, Cardiovascular & Specialty Solutions
19. Contributes to clinical trial strategy and contingency planning and implementation in partnership with other functional area including NPI projects
[Requirements]
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Minimum 1 year of clinical trial management experience
- CRA or CRC experience preferred
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
- Proficient in speaking and writing the country language and English
- Flexible mindset and ability to work at a fast-paced within small exploratory international study teams in a fast-changing environment
- Ability to work on multiple trials in parallel in different disease areas
[지원 방법]
www.careers.jnj.com 접속 -> Position Number 2306108676W 검색 -> 해당 모집 공고의 “Apply Now” 클릭 후 온라인 지원 프로세스 진행
[제출 서류]
국&영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[For more Johnson & Johnson]
- J&J Careers 유튜브 채널 : https://www.youtube.com/channel/UCZEsWOZwbcjcXHrgYq7sP4Q
- J&J Korea Facebook: https://www.facebook.com/JNJCareersKorea/
- J&J Linkedin: https://www.linkedin.com/company/johnson-&-johnson/
- J&J Corporate Page: http://www.jobkorea.co.kr/Company/1605233/Info
[유의사항]
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기 바랍니다.
- 서류 전형 합격자에 한하여 개별 통보합니다. 단, 회사 사정에 따라 지연 될 수 있습니다.
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- 모집 분야 관련하여 자세한 내용은 J&J 홈페이지에서 확인하시기 바랍니다. www.careers.jnj.com
See above.