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.

[근무조건 및 환경]

• Direct contractor - Entry (신입, 직접계약직, 이후 정규직 전환 검토)

• 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]
• 선택적 근로시간제 (Core-time제) 정규직과 동일한 복리후생 제공

[ 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

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.