Position Purpose :
Participate in clinical trial site management for Pre-POC / POC studies and critical studies in Japan and oversees the site as clinical monitoring activities by ensuring compliance with regulations, protocol(s), SOPs and overall clinical objectives.
Reviews clinical data, essential documents for the Trial Master File, clinical monitoring deliverables and assists with maintaining productive Sponsor relationships with Investigational study sites.
Description of Primary Role & Responsibility :
Conduct site feasibility and pre-trial assessment activities
Prepare IRB submissions and investigational site contracts
Conduct Site Initiation Activities where all relevant training will be given including, but not limited to; the protocol and protocol procedures, the information and consent process, SAE reporting, sample processing and shipment and drug handling and accounting.
Conduct Site Monitoring Activities according to monitoring plan including, but not limited to; drug supplies, site compliance with protocol and all current and relevant regulations, conducting source data review and verification, ensuring all serious adverse events (SAEs) have been reported appropriately
Review the study file periodically to ensure compliance with relevant SOPs and regulations, guidelines and policies and ICH GCP
Monitor patient recruitment timelines at sites
Conduct ongoing CRF discrepancy resolution
Monitor study drug requirement at sites when additional supplies need to be shipped to the site
Monitor SAE reporting by the site
Conduct Site Close-out activities
Share study team about monitoring issues including significant quality events
Document all study site visits including selection, initiation, monitoring and close-out visits as required / Send follow-up letter to site
Qualifications, Desired Behavioral and Technical Skills :
A scientific or technical degree in the healthcare area is preferred along with extensive knowledge of clinical trial methodology.
Must-Have / 要件
5+ years’ working experience as CRA
Experience working in the research and development of pharmaceutical industry
Experience working for global study
Clinical & regulatory processesThorough understanding of good clinical practices (GCP)Thorough understanding of key operational elements of clinical research (e.
g., site selection, monitoring, data acquisition and cleaning, reporting, etc)
Presentation, influencing and Communication skillsAbility to develop and deliver presentationsAbility to communicate and interact competently and professionally at all levels within a broad, complex clinical research environment.
Nice-to-Have / 以下のスキルがあればより望ましい
Experience in early drug development, early phase oncology study
Coaching junior CRAs