Careers

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 :

Ÿ직책 직급: 직책 한글 직급 협의 결정 가능

Ÿ급여 사항: 협의 결정

Ÿ고용 형태: 정규직/경력직

 

Recruitment Process:

Ÿ전형방법: 1 서류전형/2 & 3 면접전형

Ÿ제출 서류: 한글 이력서/자기소개서, 영문 이력서/자기소개서

Ÿ접수 방법 문의 사항: 온라인 지원, HR@medirama.co,kr  

Ÿ마감일: 2024 8 31 

 

Others

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Ÿ제출하신 서류는 일체 반환하지 않습니다

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Ÿ기타 문의 사항은 반드시 E-mail 문의바랍니다.