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기관 IVI(국제백신연구소)(서울) 
프로그램 IVI(국제백신연구소)(서울) Researcher (Clinical Operations Department) 채용 
마감날짜  

채용시 마감

IVI(국제백신연구소)(서울) Researcher (Clinical Operations Department) 채용

 

Researcher (Clinical Operations Department)

We are seeking a Researcher for a 2-year-regular position (renewable) at the International Vaccine Institute in Seoul, Korea to work within the Clinical Operations Department.

 

Job Description:

This position is responsible for ensuring that the rights, safety, and wellbeing of study subjects are protected and that the reported data are accurate, complete and verifiable from source documents. The CRA is also the primary link between investigators, sites and sponsors, acting as a study coordinator to ensure that clinical trials are conducted and documented as per ICH GCP guidelines, IVI SOPS, and local requirements. The CRA is also the point of contact with CRO if required.

 

Main Roles & Responsibilities:

  1. Support Project Team and ensure clinical site capacity to conduct studies
  • Assist Clinical Operations Manager (COM) with site identification, site feasibility assessment, and selection of investigational sites
  • In collaboration with the CRO, prepare essential site documents and participate in the ethics and regulatory submission and approval processes
  • Ensure availability of materials for the study (e.g., IP, fridge, worksheet/source documents, Manual of Procedures etc.) including tracking of laboratory sample transportation and shipment
  • Responsible for ensuring all key documents are present and filed as appropriate in Trial Master File (TMF)
  • Provide general support to clinical project teams according to the needs of IVI Clinical Operations
  • Maintain an awareness of the assigned study, including an understanding of the investigational products
  • Demonstrate a thorough understanding of ICH GCP, the Declaration of Helsinki, and any local guidelines as they apply to investigators, sponsors, monitors and IRBs
  • Participate in activities of Clinical Operations, including presentations at department meetings and assisting with development of clinical process and SOPs
  1. Monitoring of Investigational site as per ICH GCP and clinical monitoring plan for each study
  • Train investigators on the sponsor and regulatory requirements for conducting the study. Ensure the site has all supplies to perform the study. Participate in investigator meetings as appropriate including preparing and presenting study-related materials
  • Ensure recruitment of subjects as per the site target. Take corrective actions to encourage site recruitment and report recruitment issues promptly to COM and project team
  • Perform visits to site according to the Clinical Monitoring plan and ensure high quality standards of the study conduct
  • Assist with development of protocols, CRFs, monitoring plan including risk management plan, study-specific forms and local process as per the requirements of the study
  • In case of audit/inspection, CRA is in charge of preparing for the audit/inspection and developing the appropriate CAPAs related to clinical operation activities under COM supervision, which will be reviewed with the assigned study medical monitor

 

Job Requirements and Qualifications:

 

  1. Education Requirements
  • Bachelor/Master’s degree or equivalent
  1. Related Field Work Experience
  • 5+ years in Clinical Operations and/or Clinical Research Associate
  1. Technical and Professional Skills / Knowledge
  • Strong knowledge of GCP guidelines
  • Good Knowledge of vaccine and clinical research
  • Good knowledge of computer software (i.e., power point, excel file, word…)
  • Knowledge in Quality Management
  1. Language Proficiency
  • Fluency in English

Apply for job

 

출처: https://www.ivi.int/researcher_researcher_clinical-operations/

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