Clinical Research Associate (CRA Japanese Speaking to be based in Tokyo/Osaka)
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.
One of our key growth areas is the Asia Pacific Region in particular Japan. We started our business last year 2013 with offices in both Tokyo and Osaka. We have successfully grown our business here, and leveraging our expertise and solid relationship with our global customer base, we have been awarded new projects to conduct in Japan. Due to continued growth and expansion we are now excited to recruit several Clinical Research Associates to be part of the growing family in Japan. We have exciting projects in line and this will be an excellent opportunity to join INC Research now and tap on this golden opportunity to get exposed to global clinical projects.
•Communication - Maintains timely and effective communication among team members and site staff. Anticipates/indentifies potential issues.
•Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations. (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor. SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines. and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested; may require guidance to. respond to findings. May be responsible for assisting with the submission of regulatory packages to ethics committees and/or competent authorities.
•Monitoring - Assumes responsibility for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements;assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; and regularly reviews the status of the contents within the site regulatory binder.
•Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Utilizes multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
•Reporting and Tracking - Completes and submits visit reports according to SOP/Works Instructions (WI) requirements. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
Skills and attributes:
•BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Previous clinical or related research experience preferred. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines; basic knowledge of applicable therapeutic standards. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment. Native fluency in Japanese language (speaking, reading and writing) and basic level English language skills.
Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
We’ve got an attitude at INC: “Can do, I own it.” Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).”
Last modified on September 2, 2019
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