- Provides support to investigator sites in Japan or Japanese-speaking sites, monitors, department, business unit or function through communication of information, training sites and documentation of services pertaining to clinical trials.
- Supports the overall performance, education and training of the sites on a study level to ensure the execution of protocols are completed accurately and on time.
Essential Functions:
- Acts as the point of contact for sites, ensuring that questions, material orders and request for information are responded and detailed in an accurate and timely manner.
- Ensures that the sites are accurately trained in aspects of the protocol (following the study flow sheet) relating to the department. Provides guidance on pre-analytical aspects of the study to ensure smooth flow of data to and from the site. -
- Notifies the sites and all vital contacts via telephone/fax of all relevant critical/voice alert values/ study specific requirements.
- Places all calls to the sites delivering sponsor alert, voice alert values (VAV) and any other critical values. Answers incoming phone calls, resolves different types of exceptions within assigned timelines.
- Monitors and raises site issues through the appropriate departments/people e.g. project management to resolve and report as soon as possible.
Education and Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Knowledge, Skills and Abilities:
- Japanese language proficiency is vital as the selected candidate is required to support the sites and customers based in Japan via phone and emails, where the medium of communication is in Japanese language.
- Accurate data entry skills with intermediate digital literacy including Microsoft Office - Strong analytical, interpersonal and time management skills
- Strong client and phone service skills
- Basic knowledge of Good Clinical Practices and department principals such as pre-analytical techniques
