CRA, Clinical Development
2024-08-01 ~
2024-08-31
Responsibilities:
Acts as primary site contact and site manager of a
clinical research study, taking overall responsibility of allocated sites.
- Develops strong site
relationships and ensures continuity of site relationships.
- 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
Initiation.
- 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 related
stakeholder.
- Manages and maintains information
and documentation as appropriate and per timelines.
- Supports and/or leads audit/inspection activities as
needed.
Qualification :
- B.A./B.S. with strong emphasis in
science and/or biology
- Min. 1 years of clinical research
related experience (e.g. CRC/CRA/CTA etc)
Additional information :
직책 및 직급: 직책 및 한글 직급 협의 후 결정 가능
급여 사항: 협의 후 결정
고용 형태: 정규직/경력직
Recruitment Process:
전형방법: 1차 서류전형/2차 & 3차 면접전형
제출 서류: 한글 이력서/자기소개서, 영문 이력서/자기소개서
접수 방법 및 문의 사항: 온라인 지원, HR@medirama.co,kr
마감일: 2024년 8월 31일
Others
면접은 서류전형 합격자에 개별 통지합니다.
제출하신 서류는 일체 반환하지 않습니다
입사지원서 내용에 허위사실이 판명될 경우 입사가 취소될 수 있습니다.
기타 문의 사항은 반드시 E-mail로 문의바랍니다.