Experienced Clinical Research Associate, Osaka

*We have mutiple Onboarding Batches to accomodate to your graduation date/current situation.   Experienced Clinical Research Associate (CRA) - join our growing team in Osaka, Japan!   Medpace is growing quickly and we are seeking experienced Clinical Research Associates to join our team. We are an innovative, scientifically oriented mid-sized CRO that is focused on full-service project work. Through our fast PACE ®  ( P rofessional A chieving C RA E xcellence) Training Program, you will receive customized, expedited training, and efficient onboarding to familiarize you with Medpace systems.     WE OFFER THE FOLLOWING: Customized training program based on your experience and therapeutic background and interest; Annual company bonus; Annual merit salary increases; Defined Contribution Plan; Group term life insurance with insurance premium coverage; Insurance association benefits available; The opportunity to work from home; Flexible work hours across days within a month; Laptop, mobile phone with hotspot for internet access anywhere and home office furniture allowance for home-based CRAs; Opportunity for leadership positions/career advancement – Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, etc.; User friendly Clinical Trial Management System (CTMS) with electronic submission and approval of monitoring visit reports; Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; In-house administrative support for all levels of CRAs; Opportunities to work with international team of CRAs; and Many additional perks unmatched by other CROs! Since most studies are global trials, opportunities to collaborate with the global team/vendor and contribute to the success of the clinical trial. Opportunities to experience complex study involvement, including oncology, rare disease, phase1 First-in-Human studies. So, CRAs will gain high-level monitoring experience and contribute to society.

Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements (J-GCP); On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; Verification that the investigator is enrolling only eligible subjects; Regulatory document review; Medical device and/or investigational product/drug accountability and inventory; Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; Assess the clinical research site’s patient recruitment and retention success and offering suggestions for improvement; and Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Clinical Research Associate experience (minimum 1 year); Native level Japanese (JLPT N1) is standard, a minimum English TOEIC score of 500 or equivalent Must have a minimum of a bachelor’s degree in a health or science related field; Ability to travel 30-50%/month to