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Job Description Sr. CRA , CRA IIDuties and Responsibilities (accordingto relevant guidelines, laws and SOPs)- Performs and coordinates all aspects of the clinical monitoring and sitemanagement process in accordance with ICH GCP, FDA guidelines, localregulations and SOPs. - Conducts site visits to assess protocol and regulatory compliance andmanages required documentation Responsible for ensuring that data will passinternational quality assurance audits. - Represents the company in the global medical research community anddevelops and maintains collaborative relationships with investigational sites.Position scope:- Serves as a primary contact with individual investigational sites thatconduct clinical trials. - Successful site management contributes directly to operationalobjectives, which in turn have an impact on project profitability. - Goal is to deliver clean CRFs from an ICH GCP and SOP/WPD compliantprocess on time and within budget.RequirementsExperience:A minimum of two years(CRA) / three years(Sr. CRA) experience as a Clinical Research Associate / monitor or in a health sciencesfield / clinical research setting is required. Three years'' experience for theSenior CRA roleEducation:- Bachelor''s or higher graduate degree in a science related field, licensedor certified health care training or equivalent experience.Skills and Knowledge: - Effective oral and written communication skills.- Excellent interpersonal skills.- Strong attention to detail.- Basic computer skills and the ability to learn appropriate software.- Good English language and grammar skills.- Basic medical/therapeutic area and medical terminology knowledgepreferred.- Ability to work in a team or independently as required.- Ability to travel and spend 60 to 80% of working week at site. ÀüÇü¹æ¹ý :-1Â÷ ¼·ùÀüÇü -> 2Â÷ ¸éÁ¢ÀüÇü( HR ¹× ½Ç¹« ´ã´çÀÚ)-¼·ùÁ¢¼ö±â°£: ~ ä¿ë ½Ã±îÁö-Áö¿ø¹æ¹ý: ¿µ¹®À̷¼ À̸ÞÀÏ Áö¿ø-¼·ùÀüÇüÇÕ°ÝÀÚ ¹ßÇ¥: °³º°Å뺸 µå¸®µµ·Ï ÇÏ°Ú½À´Ï´Ù.- ¹®ÀÇ : ÀÌÁö¿µ (jiyoung.lee@ppdi.com)
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