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.
Qualifications
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; Advanced degrees or prior clinical research experience is a plus; In-House CRA position available/considered for those with no or minimal clinical research experience with rapid advancement;
Ability to travel 60-80%/month to locations nationwide is required;
Proficient knowledge of Microsoft® Office;
Strong communication and presentation skills; and
Must be detail-oriented and efficient in time management.
