핵심 정보
- 경력
- 경력 1년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직 수습기간 3개월
- 우대사항
-
- 전공생명과학, 간호학
- 외국어 능력영어가능자, 영어능통자
- 활동/경험해당직무 근무경험
- 급여
- 면접 후 결정
- 근무지역
- 서울 용산구
본 채용정보는 마감되었습니다.
(주)한국얀센에서 채용공고가 시작되면 이메일로 알려드립니다.
상세요강
At
Johnson & Johnson, we believe health is everything. Our strength in
healthcare innovation empowers us to build a world where complex diseases are
prevented, treated, and cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in pharmaceutical, medical
devices and diagnostics markets, we are uniquely positioned to innovate across
the full spectrum of healthcare solutions today to deliver the breakthroughs of
tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com/ .
- 포지션: Clinical Research Associate
- 계열사: 얀센 (Janssen)
- 근무지: 서울시 용산구
- 근무 형태: Regular
[Summary]
A
Clinical Research Associate (Site Manager I (SM I)) serves as the primary
contact point between the Sponsor and the Investigational Site.
A
Site Manager I 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.
[Main
responsibilities]
-
Acts as primary local company contact for assigned sites for specific trials.
-
May participate in site feasibility and/or pre-trial site assessment visits
-
Attends/participates in investigator meetings as needed.
-
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.
-
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.
-
Contributes to site level recruitment strategy and contingency planning and
implementation in partnership with other functional areas.
-
Ensures site study supplies (such as Non-Investigational Product (IP), lab
kits, etc.) are adequate for trial conduct.
-
Ensures that clinical drug supplies are appropriately used, handled and stored
and returns are accurately inventoried and documented.
-
Arranges for the appropriate destruction of clinical supplies.
-
Ensures site staff complete data entry and resolve queries within expected
timelines.
-
Ensures accuracy, validity and completeness of data collected at trial sites
-
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.
-
Maintains complete, accurate and timely data and essential documents in
relevant systems utilized for trial management.
-
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.
-
Reviews study files for completeness and ensures archiving retention
requirements are met, including storage in a secure area at all times.
-
Collaborates with LTM for documenting and communicating site/study progress and
issues to trial central team.
-
Attends regularly scheduled team meetings and trainings.
-
Complies with relevant training requirements. Act as local expert in assigned
protocols. Develops therapeutic knowledge sufficient to support role and
responsibilities.
-
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).
-
Prepares trial sites for close out, conduct final close out visit.
-
Tracks costs at site level and ensure payments are made, if applicable.
-
Establishes and maintains good working relationships with internal and external
stakeholders in particular investigators, trial coordinators and other site
staff.
-
May participate in the Health Authority (HA) and IEC/IRB submission and
notification processes as required/appropriate.
-
Acts as a point of contact in site management practices.
-
May contribute to process improvement and training.
Requirement
Principal
Relationships:
(Describe
the primary working relationships (internal & external) and primary
interfaces)
-
Primary Reporting Structure: Reports to a Functional Manager
-
Primary interfaces: Functional Manager, CTA, LTM and CTM.
-
Other Internal Interfaces: R&D Country Head, Therapeutic Area
Manager/Physician, Quality & Compliance Manager/Specialist, Training
Manager, Contracts & Grants, Local Drug - Safety Officer (where required)
and Site Manager team.
-
External Interfaces: Investigators and their delegates at site (trial site
personnel).
Education
and Experience Requirements:
(Describe
the minimum knowledge, skill and ability requirements for the position. Include
any degrees or certifications which are required and/or desirable.)
-
A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific
field (or equivalent experience) is required.
-
A minimum of 1 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.
[JD 확인 및 지원 방법]
www.careers.jnj.com -> Requisition number “2406178912W”검색 -> 해당 모집 공고 클릭 후,
“Apply Now”
[ 제출 서류]
영문 자유 양식의 이력서/경력기술서/자기소개서
[ 서류 마감일]
채용시 마감
[ 유의사항]
-
국가보훈
대상자
및
장애인은
관련
서류
제출
시
관계
법령에
의거하여
우대합니다.
-
서류
전형
합격자에
한하여
개별
통보합니다.
단,
회사
사정에
따라
지연될
수
있습니다.
-
입사
지원
서류에
허위
사실이
발견될
경우,
채용
확정
이후라도
채용이
취소될
수
있으며
향후
채용이
제한됩니다.
-
제출된
서류는
반환되지
않으며,
별도
요청
시
삭제합니다.
www.careers.jnj.com
복리후생
- 지원금/보험
- 건강검진, 의료비지원(본인), 각종 경조사 지원, 의료비지원(가족), 헬스비 지급, 자...
- 급여제도
- 퇴직연금, 장기근속자 포상, 성과급, 가족수당, 4대 보험
- 선물
- 명절선물/귀향비
- 교육/생활
- 사내동호회 운영
- 조직문화
- 캐주얼데이
- 리프레시
- 연차, 경조휴가제, 휴가비지원, 육아휴직, 남성출산휴가
기업정보
이 기업의 다른 공고 (7건)
이어보는 Ai매치 채용정보
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.
사람인 인공지능 기술 기반으로 맞춤 공고를 추천해드리는 사람인의 채용정보제공 서비스입니다.