[노보텍아시아코리아] CRA PASS(PMS/OS) 경력직 채용

[모집기간]

07월 08일 ~ 08월 07일

[담당업무]

-CRAs primary responsibility is to build relationships with Principal Investigators, study coordinators, 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.

[자격요건]

-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

[우대사항]

-PMS과제 2년 이상 경력자 우대

-의/약학, 간호학, 생명/환경공학

[채용공고]