| 業務内容 |
Verify that the rights and well-being of subjects are protected, the reported trial data are accurate, complete, and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), GCP, and applicable regulatory requirement(s); Ensure site compliance while conducting qualification, study initiation, routine monitoring, and study site close-out visits for research sites according to Sponsor Standard Operating Procedures (SOPs); Serve as the primary resource to the clinical investigator and site staff; Maintain close collaboration, interaction, and effective working relationships with internal cross-functional teams; Ensure quality completion of visit reports, follow-up letters, and maintenance of study-related databases and ClinTrak ® Monitoring Portal; |
|---|---|
| 雇用形態 | 正社員 |
| 応募資格 |
Bachelor's degree in a health or science related field + at least 2 years of clinical monitoring experience or earlier if the below competencies/achievements are demonstrated: Broad knowledge of the field of clinical research; Satisfies essential functions of an independent CRA which is demonstrated by the number of months resourced and number of independent on-site visits performed*; May act as a Lead CRA (dependent upon performance and experience); Demonstrated ability to maintain desired report accuracy and metrics; Adequate feedback from site audits/inspections and CRA on-site/remote evaluation; Uses interpersonal skills in order to communicate and manage relationship with sponsors, sites, and internal associates; Proficient knowledge of Microsoft® Office; Outstanding communication skills; Must be detail-oriented and efficient in time management. Work effectively and independently from home-based office, if permitted. Approximately 60-80% non-local, national travel is required;Experience as a Clinical Research Associate; Must have and maintain a valid driver’s license and the ability to drive to monitoring sites. This specifically applies in the US, Canada, any countries where cars/car allowance are provided by company, and other countries dependent on monitoring travel and patterns as designated by Company. Bilingual Japanese and English |
| 英語力 | ネイティブレベル |
| 年収 | 500万 〜 800万円 |
| 給与詳細 | 年収：500万円～800万円 |
| 勤務地 | 東京都 |
| 備考 |
