한국 MSD의
임상부서인 GCTO팀에서 CRA로 근무해주실분을 다수 모집합니다. 지원자격은Global monitoring 경력이
있으신 분(Oncology
study 선호)입니다. (최소 1년
5개월의 경력
요구)
관련하여 궁금한
점이 있으신 분들께서는 kr_recruit@merck.com 으로
문의 주십시오. 지원
방법은 하단의
내용 확인 부탁드립니다..
Acts as primary site contact and site manager throughout all
phases of a clinical research study, taking overall responsibility of allocated
sites.
•Develops strong site
relationships and ensures continuity of site relationships through all phases
of the trial.
•Performs clinical study
site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs,
Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
documents.
•Gains an in-depth
understanding of the study protocol and related procedures.
•Coordinates & manages
various tasks in collaboration with other sponsor roles to achieve Site Ready.
•Participates &
provides inputs on site selection and validation activities.
•Performs remote and
on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased
o Subjects’ right, safety and well-being are protected
•Conducts site visits
including but not limited to validation visits, initiation visits, monitoring
visits, close-out visits and records clear, comprehensive and accurate visit
& non-visit contact reports appropriately in a timely manner.
•Collects, reviews, and
monitors required regulatory documentation for study start-up, study
maintenance and study close-out.
•Communicates with
Investigators and site staff on issues related to protocol conduct,
recruitment, retention, protocol deviations, regulatory
documentation, site audits/inspections and overall site performance.
•Identifies, assesses and
resolves site performance, quality or compliance problems and escalates per
defined CRA Escalation Pathway as appropriate in collaboration with CRM, PLM
and RCPM.
•Manages and maintains
information and documentation in CTMS, eTMF and various other systems as
appropriate and per timelines.
•Contributes to CRA team
knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and
sharing best practices as appropriate/required.
•Supports and/or leads
audit/inspection activities as needed
Competency Expectations:
•Fluent in Local Languages
and English (verbal and written) and excellent communication skills, including
the ability to understand and present technical information effectively.
•Good understanding and
working knowledge of clinical research, phases of clinical trials, current
GCP/ICH & country clinical research law & guidelines.
•Good understanding of
Global, Country/Regional Clinical Research Guidelines and ability to work
within these guidelines.
•Hands on knowledge of Good
Documentation Practices
•Proven Skills in Site
Management including management of site performance and patient recruitment
•Demonstrated high level of
monitoring skill with independent professional judgment.
•Good IT skills (Use of MS
office, use of various clinical IT applications on computer, tablet and mobile
devices) and ability to adapt to new IT applications on various devices.
•Ability to understand and
analyze data/metrics and act appropriately
Behavioral Competency Expectations:
•Effective time management,
organizational and interpersonal skills, conflict management, problem solving
skills
•Able to work highly
independently across multiple protocols, sites and therapy areas.
•High sense of accountability
/ urgency. Ability to set priorities and handle multiple tasks simultaneously
in a changing environment.
•Works effectively in a
matrix multicultural environment. Ability to establish and maintain culturally
sensitive working relationships.
•Demonstrates commitment to
Customer focus.
•Works with high quality
and compliance mindset | 
