핵심 정보
- 경력
- 신입·경력(년수무관)
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직
- 급여
- 면접 후 결정
- 근무요일
- 주 5일(월~금)
- 근무지역
- 서울 용산구
본 채용정보는 마감되었습니다.
한국존슨앤드존슨메디칼(주)에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
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 II
2. 계열사: 한국얀센
3. 근무지: 서울시 용산구
[Summary]
Clinical Research Associate(CRA) serves as
the primary contact point between the Sponsor and the Investigational Site.
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. Participate in site feasibility and/or
pre-trial site assessment visits
3. Responsible for executing activities
within site initiation and start-up, preparation and conduct of site
monitoring, site management and site/study close-out according to SOPs, Work
Instructions 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.
4. 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.
5. Contributes to site level recruitment
strategy and contingency planning and implementation in
partnership with other functional areas.
6. Ensures site staff complete data entry and resolve
queries within expected timelines.
7. Ensures accuracy, validity and completeness of data
collected at trial sites
8. Maintains complete, accurate and timely
data and essential documents in relevant systems utilized for trial
management.
9. 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.
10. Reviews study files for completeness and
ensures archiving retention requirements are met, including storage in a secure
area at all times.
11. Collaborates with LTM for documenting and
communicating site/study progress and issues to trial central team.
12. Complies with relevant training
requirements. Act as local expert in assigned protocols. Develops therapeutic
knowledge sufficient to support role and responsibilities.
13. 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).
[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 required. 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.
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number 1805659900W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”
[제출 서류]
영문 자유 양식의 이력서&자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 서류를 MS-Word 나 PDF 로 된 한 개의 파일로 미리 준비 하시기
바랍니다.
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개별 통보합니다. 단, 회사 사정에 따라 지연
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www.careers.jnj.com
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