“First for Innovation &amp; Value”<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" />

JOB DESCRIPTION

Job Title : Medical Clinical Research Associate

Job Position : Temparary (1 year contract )

Report to : Clinical Research manager

Working Location : Seoul

Job Porpose :

To perform activities in the preparation, initiation, monitoring and closure for an agreed number of centres in all clinical studies according to AZ Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations. To ensure quality and quantity commitments are achieved in a timely manner.

KEY RESPONSIBILITIES (Key activities or measurements)

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

· Actively participate in internal and external meetings (e.g. Local Study Delivery Team meetings, country investigators meetings and so on).

· Contribute to the selection of potential investigators.

· Initiate, monitor and close study sites in compliance with AZ Procedural Documents.

· Lead initiation, maintenance and closure of the study master file (SMF), investigator study file (ISF) in compliance with AZ Procedural Documents.

· Share information on patient recruitment and study site progress within Local Study Delivery Team.

· Update IMPACT with data from centres in a timely manner.

· Manage study supplies at study site level.

· Manage study drug supplies and accountability at the study sites.

· Train, support and advise study personnel in study related matters.

· Perform source data verification according to SDV plan.

· Achieve the respective assignment according to timetable requirements.

· Ensure accurate and timely reporting of Serious Adverse Events.

· Ensure data query resolution.

· Prepare for activities associated with audits and regulatory inspections in liaison with CQA.

· Provide input into process development and improvements.

· Track and manage agreed payments at study site level.

· Keep track on research intelligence in local market.

· Contribute to process improvements: work with other members of the organisation to share knowledge, experience and best practices.

· Work with Data Management to ensure the quality of the study data

QUALIFICATIONS

· University degree and / or equivalent. Majored in pharmacy or Nursing

· Excellent knowledge of spoken and written English.

· Good ability to learn and to adapt to work with IT systems.

Functional Skills

· Excellent knowledge of relevant AZ Procedural Documents.

· 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 knowledge in Clinical Development.

· Excellent understanding of the Clinical Study Process.

· Excellent knowledge of the Monitoring Process.

· Good understanding of the Study Drug Handling Process.

· Good understanding of the Data Management Process.

Management Skills

· Basic decision-making skills.

· Basic skills in handling crisis situations.

Application &amp; Contact Information

마감일: 채용시까지

제출서류: 1) 이력서 (국문 혹은 영문) 2) 자기소개서 (신입) 혹은 경력기술서 (경력)
(각종 증빙서류는 서류전형합격자에 한해 추후제출)

서류접수 방법:

1. www.azk.co.kr 접속-> 채용정보

1. 기본정보 입력, 입사지원서 및 자기소개서(개별양식 가능)첨부

2. 모집부문: 지원직종에서 "Medical CRA" 선택

3. 구분: 경력/신입 선택

4. 지원서류 파일명: "지원분야(경럭/신입)_지원자성명_이력서/자기소개서

채용문의: recruit.korea@astrazeneca.com