담당업무 

• ㆍCRAs 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. 
• ㆍIn 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.
• ㆍEnsure 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. 
• ㆍMonitoring 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.
• ㆍResponsible 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.
• ㆍProvide 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.
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자격요건

ㆍ학력 : 대졸이상 

 ㆍon-site monitoring 경력 / 허가 임상 경력 3년 이상 또는 1년 이상의 BA/BE 경력 우대

Qualifications & Experience: 

• ㆍGraduate in a clinical or life sciences-related field. 
• ㆍRelevant experience/qualifications in allied professions may also be considered. 
• ㆍMust have good time management skills, attention to detail, be able to work well in a team, and be computer literate.
• ㆍPreferably experience of working in the research, pharmaceutical industry or a related field per job level.