[Novotech] CRA  °æ·Â Á¤±ÔÁ÷ ä¿ë

³ëº¸ÅؾƽþÆÄÚ¸®¾Æ(ÁÖ)

¸ðÁýºÎ¹® ¹× ÀÚ°Ý¿ä°Ç

´ã´ç¾÷¹« ÀÚ°Ý¿ä°Ç Àοø

     

    Responsibilities: 
    • *CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. 
    • *In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed.
    • *Ensure recruitment of participants as per the site target. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plan(s) and update as required. 
    • *Monitoring of investigational sites as per ICH GCP ¡×5.18 (Monitoring) and the Clinical Monitoring Plan (CMP) for each study. This includes all monitoring visit types across all phases of a clinical trial including Site Selection, Site Initiation, Site Monitoring and Site Close Out, unblinded pharmacy visits, and co-monitoring visits. Visits can be conducted either onsite or remote as per CMP.
    • *Responsible for quality study management and monitoring deliverables at the country and site level; follows project requirements and applicable country rules, with moderate oversight from the LM or PM.
    • *Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM/LCRA according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs. Escalate all key issues as per Issue Escalation SOP.

[±Ù¹«ºÎ¼­ ¹× Á÷±Þ/Á÷Ã¥]

    Á÷±Þ/Á÷Ã¥: »ç¿ø

Experience and Qualifications

  • At least  1year of independent clinical monitoring experience 
  • *Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level.
  • *For Sr. CRA only, the proven experience of capacity to take the Lead CRA role and responsibility 
  • *Strong communication skill both in written and spoken Korean & English 
  • *Excellent interpersonal and team collaboration skill with a genuine commitment to contributing to the development of innovative treatment
  • [ÀÚ°Ý¿ä°Ç]

    °æ·Â»çÇ×: °æ·Â(3³â ÀÌ»ó )
    Çз»çÇ×: ´ëÇб³(4³â)Á¹¾÷


    [¿ì´ë»çÇ×]

    Àü°ø°è¿­: ÀÇ/¾àÇа迭

    1 ¸í

    ±Ù¹«Á¶°Ç

    • °í¿ëÇüÅÂ: Á¤±ÔÁ÷(¼ö½À±â°£6°³¿ù)
    • ±Þ¿©Á¶°Ç: ¿¬ºÀ ÇùÀÇ ÈÄ °áÁ¤

    ÀüÇü´Ü°è ¹× Á¦Ãâ¼­·ù

    • ÀüÇü´Ü°è: ¼­·ùÀüÇü > Æù½ºÅ©¸®´× > ½Ç¹«Áø¸éÁ¢ > ·¹ÆÛ·±½ºÃ¼Å© > ÃÖÁ¾ÇÕ°Ý
    • Ãß°¡ Á¦Ãâ¼­·ù
      ¿µ¹®À̷¼­(MS-Word ¶Ç´Â PDF)

    Á¢¼ö¹æ¹ý

    ä¿ë½Ã ¸¶°¨

    • Á¢¼ö¹æ¹ý: ÀÚ»ç ȨÆäÀÌÁö

    ±âŸ À¯ÀÇ»çÇ×

    • ÀÔ»çÁö¿ø¼­ ¹× Á¦Ãâ¼­·ù¿¡ ÇãÀ§»ç½ÇÀÌ ÀÖÀ» °æ¿ì ä¿ëÀÌ Ãë¼ÒµÉ ¼ö ÀÖ½À´Ï´Ù.

    full.png?from=upload


    full.jpeg?from=upload

    00