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Seoul, Seoul, South Korea
Job reference: R-001826
Posted date: Jun. 10, 2019

Major responsibilities

 ·       Obtain and maintain essential documentation in compliance with ICH-GCP, AZ Procedural Documents and local regulations both in the office

·       Actively participate in local Study Delivery Team meetings if required.

·       Support site qualification visit and initiation visit by preparing essential documents in the office.

·       Proactively identify study-related issues and escalates as appropriate.

·       Update IMPACT and other systems with data from centres as per required timelines.

·       Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability in the office.

·       Provide IP supplies after database lock and perform the pharmacy monitoring at the site if required.

·       Ensure accurate and timely IRB submission (Initial, amendment and notification).

·       Prepare and negotiate site specific Clinical Study Agreement with institution including budgets.

·       Provide QC of translated documents (e.g., protocol, ICFs and etc.)

·       Perform electronic Trial Master File periodic QC.

·       Develop site specific informed consent form and any local documents in the office.

·       Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Trial Master File.

·       Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).

Minimum Requirements and Preferred Background

·       University degree in related discipline, preferably in life science, or equivalent qualification.

·       Fluent knowledge of spoken and written English.

·       Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.

·       Good knowledge of relevant local regulations.

·       Good medical knowledge in relevant AZ Therapeutic Areas.

·       Basic understanding of the drug development process.

·       Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

·       Ability to travel nationally as required.

Competencies and Skills

 ·       Ability to deliver quality according to the requested standards.

 ·       Ability to work in an environment of remote collaborators.

·       Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.

·       Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.

·       Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.

·       Good analytical and problem solving skills.

 ·       Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.

 ·       Good cultural awareness.

·       Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment.

·       Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

[ 고용형태 ]

신입계약직 및 정규직(경력) 0

[ 자격요건 ]

신입계약직 및 정규직: 약학 / 제약학 / 생명과학

공학 / 유전공학 / 화학 / 생물학 학사학위 이상 취득자

해외여행의 결격사유가 없는 분

남자의 경우 병역 필 / 면제인 분

국어 / 영어 의사소통이 능통한 분

[근무조건 및 환경]

In-house CRA Contractor, Entry (신입계약직)

  • Contract period could be max. 2 years. Changing position could be considered after 2 years in current position [계약직 기간 동안(최대 2년) inhouse CRA position 고정]

In-House CRA 모집 (신입계약직)
Clinical Development

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