※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
- Stay on top of the property, level of difficulty and content of a protocol and commit to preliminary research as a Monitor. Find out optimal Investigator(s) for the trial and obtain the agreement on the study design by fully deliberating at the stage of research.
- Perform all the necessary procedures required by GCP, such as the request for participation in a clinical trial, contract, supply of trial products, provision of safety information related to SAEs, etc., CRF collection, close of a clinical trial, etc., in a timely and prompt manner.
- Make efforts to improve the quality of patients and entry speed to contribute to earlier application for new drug approval and earlier acquisition of the approval.
- Follow the registered subjects who are participating in the trial (on trial products) and investigator(s). Also, collect the CRFs with agreed timeline and take prompt action to discrepancy.
- Minimum of three years' experience as CRA is preferred.
- Knowledge of clinical development and GCP. Basic to intermediate medical and science knowledge.
- Pharmacy, Nursing, Clinical Lab. Technology etc. preferred.
- Bachelor degree of science in principal. Master degree preferred.
■English required for the following tasks:
- SDV and query handling by using EDC (InForm, English version) - Working on IV/WRS for patient tracking and Drug accountability
- Supporting trial site to contact several help desk (IWRS, EDC, central lab, etc.)
- CRA should be able to read and understand global SOP, monitoring guideline, IV/WRS manual, etc. in English)
- Writing a Monitoring Visit Report (all Monitoring report must be written in English) preferred TOEIC score > 500
- Business level skills in MS-Word, MS-Excel, MS-PowerPoint etc.
- Great Team Worker and High Cooperativeness
- Strong communication skills with internal and external stakeholders
- Quality mindset
- Proactive mindset
- Logical thinking
■CRA who has below experience/knowledge is more than welcome:
- previously/currently worked in therapeutic area of Diabetes, Growth hormone or Haemostasis
- worked on a Global trial
- had an inspection by PMDA or other Health Authority
- had an internal company audit
- done Monitoring activity based on ALCOA principal
- worked through whole one clinical trial (from site selection to site closure)
- done KOL management
- handled more than 50 patients at the same time.
- worked on Phase 2/3 trial
- worked on recent electric-infrastructure like EDC or IV/WRS
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.