ICON Clinical Research Senior CRA in Tokyo, Japan
"At ICON, it's our People that set us Apart"
ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 83 locations in 38 countries and has approximately 12,600 employees. Further information is available atwww.iconplc.com
- Senior Clinical Research Associate* (Tokyo or Osaka)
- Role Responsibility*
Working within a highly qualified team you will identify, select, initiate and close-out investigational sites for clinical studies in phases II – III ensuring that applicable regulations and principles of ICG-GCP are adhered to
Working independently and proactively to coordinate all necessary activities required to set up and monitor a study, completing accurate study status reports and maintaining study documentation
Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested
Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
Managing sponsor generated queries efficiently and responsible for study cost effectiveness
Dependent on level of experience you may assist in training and mentoring less experienced CRA’s and/or manage CRA’s working on international projects
- Experience and Qualification** *
1+ years of monitoring experience in phase IIII trials as a CRA
Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
- Native Japanese level* and conversational English at least
Excellent communication and interpersonal skills, both written and verbal enabling you to deal with queries in a timely manner
Ability to produce accurate work to tight deadlines within a pressurized environment
- Benefits of Working in ICON*
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.