Summarized Purpose:
- Provides support to investigator 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. Uses the tools provided to answer all questions, takes orders and ensure clean data at the earliest point in time.
Essential Functions:
- Acts as the point of contact for sites, ensuring that questions, material orders and request for information are responded and documented in an accurate and timely manner. Ensures that the sites are properly 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.
- Triages calls where necessary to appropriate individual/departments and follow through to resolution.
- Resolves queries so that efficient and timely sample analysis is undertaken by the laboratory so report turn around time is met. Continually reviews exceptions to resolve so that the data is cleaned within the agreed timelines.
- Notifies the sites and all necessary 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 escalates site issues through the appropriate departments/people e.g. project management to resolve and report as soon as possible. Ensures that all site issues are communicated and followed up to resolution, primarily to site and monitor. Reviews site performance metrics to educate where needed or to report back to monitor or sponsor. Informs site of the results or reasoning not to proceed.
- Follows the specifications and scope of work to evaluate requests for any additional test(s) (test performed in protocol) to be added to a sample. Evaluates the request for out of protocol testing following Scope of work for study. Facilitates requests to the appropriate person.
- Coordinates and resolves issues with samples at time of scanning to have the samples in the database and reported as soon as possible.
Job Qualification
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Knowledge, Skills and Abilities:
- Mandate to be fluent in Japanese and English langaugese (Speaking, Reading, Writing)
- Accurate data entry skills with intermediate computer skills 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 technique
- Excellent verbal communications and customer service skills in the English language - additional languages are an advantage
- Critical thinking and problem solving skills to support quality decision making
- Good written and oral communication skills
- Ability to work in a collaborative team environment
