Clinical Research Associate（CRA） / 外資系治療機器メーカー
|職種||Clinical Research Associate（CRA）|
The Clinical Research Associate （CRA） position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice （GCP）/ICH and Japan Code of Regulations is required; Additional Regulatory experience would be welcomed. A broad understanding of essential study documentation is critical.
In view that Own company is a global company the CRA candidate will have broad exposure to clinical research tasks as a combination of in house and field work. This CRA position will report to local Project Manager and works closely with global CRA manager as well as with the Own company Global team including and not limited to working with the Regional Director of Clinical Affairs Project Manager（s） and Clinical Project Team （USA Japan Israel） to support various aspects of a Clinical Trial and related regulatory activities. The CRA will also be interacting with local Business team as needed.The job holder’s duties or responsibilities are not limited to those listed below.
The job holder is expected to perform other duties and responsibilities as assigned by the Engineering team leader
The job holder’s duties and responsibilities include any of the following:
Field CRA Responsibilities
・ Conduct site qualification initiation monitoring and closeout visits and create documentation of such through accurate and detailed visit reports.
・ Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
・ Review all source records for patient safety and ensure complete documentation of all subject safety events.
・ Review regulatory binder to ensure complete accurate and up to date regulatory compliance at the site.
・ Ensure compliance with protocol and overall clinical objectives.
・ Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
・ Ensure investigator involvement in the study and IRB/EC oversight.
・ Follow through after visit to outstanding requests/needs are fulfilled.
・ Raise issues of significance to the appropriate level for resolution.
・ Able to help site navigate informed consent issues and support IRB approval process.
These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level capable contribution level and company need.
Required Knowledge and Skills:
・ Minimum of a 2 ・ 4 year University degree preferably in life sciences field and basic familiarity with medical terminology
・ Basic computer skills with proficiency in Microsoft Word and Excel required; PowerPoint and Database experience desirable
・ Ability to foster relationships with clinical sites and colleagues
・ Ability to support several projects simultaneously a flexible working style and attention to detail are essential
・ Able to work independently with excellent time management skills
・ Excellent work ethic with desire to be a valuable contributing team member
・ Preferred location in Tokyo area
・ Proficient in English is a MUST.
・ Knowledge of clinical trial processes and regulations in Japan
・ Understanding of principles implementation and maintenance of regulations.
At least 2 3 years relevant industry experience in clinical research environment preferable from Medical Device industry. Approximately 50% travel that will vary over time including limited international travel to USA Israel （able to obtain international travel passport and visas where required）.
|年収||500万円 - 800万円|