담당업무 / 자격요건 및 우대사항
· 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)
[ 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
서울 - 송파구
자기소개서는 이력서 2페이지부터 자유롭게 기재하되, 파일명은 “AZK_신입CTA_이름”으로 저장하여 지원