핵심 정보
- 경력
- 경력 3년 ↑
- 학력
- 대졸(4년제) 이상
- 근무형태
- 정규직 수습기간 3개월
- 급여
- 면접 후 결정
- 근무지역
- 서울 용산구 (재택근무 가능)
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/ .
1. 포지션: Senior.
Clinical Research Associate
2. 계열사: 한국얀센 (Janssen)
3. 근무지: 서울시 용산구
4. 근무 형태: Regular
[Summary]
A Senior. Clinical Research
Associate (Site Manager II) in Early Development & Clinical Pharmacology
(ED&CP) serves as a primary contact point between the sponsor and the
investigational site (both commercial and hospital) for the conduct of complex
early development and/or clinical pharmacology studies. A Site Manager II is
assigned to trial sites ensuring inspection readiness through compliance with
the clinical research protocol, company's Standard Operating Procedures (SOP),
codes of Good Clinical Practice (GCP), Healthcare compliance (HCC) requirements,
applicable regulations and guidelines from start-up through data-base lock.
Responsibilities include site assessments, pre-trial assessments, site
selection, site initiation, subject recruitment and retention, monitoring and
close-out. Partners with the Clinical Trial Assistant (CTA, Trial Manager (TM)
and Global Trial leader (GTL) to ensure overall site management while
performing trial related activities for assigned protocols.
A Site Manager II may contribute to
process improvement, training and mentoring of other Site Managers.
[Responsibilities]
Ø Participates
in site assessments, conducts pre-trial site assessment visits and/or
participates to study feasibility assessments, providing recommendation from
local area about site/investigator selection in collaboration with the trial
team.
Ø Acts as
primary contact for assigned sites for specific ED&CP trials and works
closely with TM and trial central team regarding study progress and issue
resolution.
Ø Attends/participates
in investigator meetings as needed.
Ø Responsible
for executing activities within site initiation and start-up, site monitoring,
site management and site/study close-out per internal SOPs, other procedural
documents and policies. Responsible for the implementation of ARBM (Analytical
Risk Based Monitoring) model at the site level when applicable. Monitors study
progress at site using study specific systems and available reports/dashboards.
Ø 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 and sponsor level.
Ø Contributes
to site level recruitment strategy and contingency planning and implementation
in partnership with other functional areas to achieve clinical research target.
Ø Ensures
site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial
conduct.
Ø In
collaboration with Pharmacy Investigational Product Specialist (PIPS) and Site
Investigational Product Specialist (SIPS), ensures that clinical drug supplies
are appropriately handled, administered, and stored. Ensures strict adherence
to investigational product preparation and administration guidelines. Ensures
clinical drug supplies are appropriately inventoried accounted and returned as
applicable including maintenance of accurate and complete documentation.
Ø Ensures
site staff complete the data entry and resolve queries within expected
timelines. Set up plan to improve data entry in collaboration with TM when
needed.
Ø Ensures
accuracy, validity and completeness of data collected at trial sites. Ensures
appropriate measures are in place for maintenance of the blind when applicable.
Ø 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, ensure that they are consistent with
all data collected and with the information in the source documents.
Ø Maintains
complete, accurate and timely data and essential documents in systems utilized
for trial management.
Ø Fully
documents trial related activities with respect to study monitoring. Writes
visit reports and 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.
Ø Reviews
Investigator Site File for completeness and ensures archiving retention
requirements, including storage in a secure area at all times.
Ø Collaborates
with TM for documenting and communicating site/study progress and issues to
trial central team.
Ø Attends
regularly scheduled team meetings and trainings.
Ø Complies
with relevant training requirements. Acts as local expert in assigned
protocols. Develops sufficient therapeutic area and early development knowledge
to support roles and responsibilities. Works across therapeutic areas dependent
upon ED&CP business needs.
Ø Works
closely with TM to ensure Corrective Action Preventive Action (CAPA) is
completed for QA site audits or inspection and for quality issues identified at
the site during routine monitoring and other visit types, e.g. On Site Quality
Monitoring Visit (OSQMV).
Ø Prepares
trial sites for close out, conduct final close out visit.
Ø May review
and manage site specific informed consent forms in accordance with GCO SOPs,
procedural documents and applicable regulations.
Ø May
participate in the HA and IEC/IRB submission and notification processes as
required/appropriate.
Ø Tracks
costs at site level and ensure payments are made, if applicable or collaborates
with C&G in charge of site payments
Ø Establishes
and maintains good working relationships with internal and external
stakeholders, in particular investigators, trial coordinators, other site staff
and key contacts in Early Development and/or Clinical Pharmacology.
Ø Coordinates
site level lessons learned activities.
Ø Acts as a
subject matter expert in site management practices
Ø Assigned as
a coach and mentor to less experienced SMs, as needed and may perform
accompanied site visits as delegated by FM
Ø Will lead
and/or contributes to process improvement and training, as needed
Ø Will Lead
and/or participates in special initiatives as assigned
Ø Will assume
additional responsibilities or special initiatives such as “Champion” or
“Subject Matter Expert.”
Ø This is not
an exhaustive, comprehensive listing of job functions. May perform other duties
as assigned.
Ø Principal
Relationships:
Ø Primary
Reporting Structure: Reports to Functional Manager (FM).
Ø Primary
interfaces: FM, CTAs, TMs, SMs, PIPS, SIPS, Site Strategic Leads (SSLs), GTLs,
Study Responsible Physicians (SRP), Quality & Compliance
Manager/Specialist, Local Safety Officer
Ø Other
Internal Interfaces: Contract and Compliance Services (CCS), GPLs, TA
representatives, Integrated Data Analytics and Reporting (IDAR), Bioresearch
Quality and Compliance (BRQC), ED&CP Head/US ED&CP Head, ED&CP
Business Operations & Quality Leader and others as required
Ø External
Interfaces: Investigational Site Staff and others as required
Ø *We have
decided to hire # 0 candidates for the Study Start-up Team.
[Requirements]
Ø A minimum
of a BA or BS degree in Life Sciences, Nursing or related scientific field (or
equivalent experience) is required.
Ø A minimum
of 3 years 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. Experience in monitoring ED&CP
studies is preferred.
Ø Specific
therapeutic area experience/knowledge may be required. Strong knowledge of
ICH-GCP, company standard operating procedures, local laws and regulations,
assigned protocols and associated protocol specific procedures including
monitoring guidelines. Strong IT skills in appropriate software and company
systems.
Ø Willingness
to travel with occasional/regular overnight stay away from home depending on
the region.
Ø Proficient
in speaking and writing the country language and English. Good written and oral
communication skills.
Ø Flexible
mindset and ability to work at a fast pace within small exploratory
international study teams in a fast-changing environment.
Ø Ability to
work on multiple trials in parallel in different diseases are
[지원 방법]
www.careers.jnj.com 접속 ->
Position Number "2406176310W" 검색 -> 해당 모집 공고의 “Apply
Now” 클릭 후 온라인 지원 프로세스 진행
[제출 서류]
영문 자유 양식의 이력서/자기소개서
[서류 마감일]
채용시 마감
[유의사항]
- 국가보훈 대상자 및 장애인은 관련 서류 제출 시 관계 법령에 의거하여 우대합니다.
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