[Novotech] CRA PASS ( PMS/OS) 경력직 채용

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.

[근무부서 및 직급/직책]

직급/직책: 사원

Experience and Qualifications

• * At least 2years 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

[자격요건]

경력사항: PMS 경력(2년 이상 )
학력사항: 대학교(4년)졸업

[우대사항]

전공계열: 의/약학계열