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Location
Seoul
Salary
Competitive Salary
Job Type
Permanent
Ref
BH-19342
Contact
Richard Hao
Contact email
Email Richard
Posted
大约 13 小时 前
Seoul, South Korea
Industry: Pharmacy, Biotech
 
We are a rapidly expanding global CRO with offices in the US, China, Europe, and Singapore, and we are actively building our clinical operations team in Korea.
 
Job Description Summary 
 
Your key responsibilities：
  • Performs site qualification,site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
  • Conduct below activities followed Clinical Monitoring Plan
➢ Assesses site processes.
➢ Conducts Source Document Review of appropriate site source. documents and medical records.
➢ Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
➢ Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
➢ Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
➢ Verifies site compliance with electronic data capture requirements.
  • Perform investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets.

Requirements:
  • Minimum of 2 years prior clinical research or monitoring experience.
  • Excellent oral and written communication skills in English, including proficient presentation skills required.
  • Excellent communication, collaboration, and problem-solving skills.
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience.
  • Competent in written and oral English and local language.


BeathChapman Pte Ltd