Japan
about 11 hoursThis project supports the monitoring of clinical trials at participating medical institutions, helping ensure that trials follow Good Clinical Practice (GCP) requirements and study protocols while protecting participants’ rights and safety. You will independently oversee monitoring activities across the trial lifecycle, from site start-up and staff training through progress checks, source data verification, and closeout. The role is suited to a CRA with at least three years of industry-sponsored clinical trial monitoring experience and experience with global studies.
The client is an international contract research organization combining global clinical research expertise with knowledge of the Japanese market. Its services span clinical trial monitoring and other development activities for domestic and international studies. You’ll gain hands-on exposure to global trial practices while contributing directly to study quality and participant protection. The position is based in Tokyo, with occasional remote work potentially available after onboarding and with manager approval.
Select appropriate trial sites and investigators in collaboration with relevant stakeholders.
Review study schedules and site contract details, and explain trial procedures to site staff.
Track enrollment and overall site progress, identifying issues that could affect trial timelines.
Collect and review case report forms, verifying reported data against source records.
Confirm investigational product delivery, supply management, and return at assigned sites.
Prepare accurate monitoring reports and document follow-up actions.
Complete trial closeout activities and verify that required procedures and documentation are in order.
Experience using a clinical trial management system, such as Veeva CTMS.
Experience reading and writing in English for work-related activities.
Experience training or mentoring junior colleagues.
Fixed-Term Employee (Cornerstone) The successful candidate will be employed by Cornerstone on a fixed-term employment contract and assigned to a client project delivered and managed by Cornerstone.
