INTRODUCTION TOCLINICAL RESEARCH ASSOCIATE (CRA)
Job Description:
The CRA will be the primary contact for all investigational sites participating in the clinical research project. The CRA will be expected to build and maintain strong relationships with the Principal Investigators and clinical site staff to ensure quality and efficiency of data collection and ongoing compliance with local and international regulations. The CRA will also be required to interact with senior leadership within a company as well as United States based clients. The position requires a significant amount of travel. The high-level, routine deliverables consist of: investigational site identification and training, study-specific training of Clinical Research Coordinators (CRC), weekly enrollment tracking by site, case report form and data query management with sites (including collection and quality), and follow-through between research sites, client sponsor and the associated core labs.
Specific Duties and Responsibilities:
• Develops site monitoring plans and budgets.
• Participates in the site initiation process, including scheduling monitoring activities with
site personnel.
• Initiates investigational sites.
• Performs interim and site close out visits.
• Assists in planning, preparing, and distributing materials for investigator and coordinator
meetings, and for study-related training.
• Attends Investigators’ Meetings and CRC Training Symposia
• Assists study management with the development, review, approval and distribution of
study-related documents including Case Report Forms (CRFs), study protocols, study
manuals, and other study tools.
• Assists study management in the execution of clinical studies according to protocol,
Corporate and GCP standards.
• Manages device accountability, inventory, and distribution.
• Monitors on-going compliance to study protocols and site adherence to local and
international regulatory guidelines.
• Prepares and participates in presentation of protocols and other study conduct
requirements at investigational sites.
• Oversees subject screening and enrolment at assigned clinical sites.
• Manages distribution, collection and tracking of regulatory documentation to ensure compliance at the investigational sites, sponsor client central file and at a company.
• Tracks and reports progress of studies including patient enrolment/screening, data
collection, and adverse event documentation and reporting.
• Assists in data query and resolution process, as required.
• Identifies and gathers missing or incomplete data from the investigational sites.
• Conducts site visits, as necessary. Acting as a company liaison, works with clinical sites
to resolve any site related issues quickly and effectively.
• Provides on-call help for sites, as well as on-going site training.
• Assists Clinical staff with the development and implementation of corrective actions for
addressing non-compliance issues at individual sites and across the study.
• Assists Clinical staff in identifying sites to be audited by either Corporate Compliance or
Clinical staff. Assists with study site audits.
• Assists with the development, review and maintenance of clinical infrastructure at a company such as drafting or reviewing SOPs and Work Instructions.
Minimum Education, Experience and Other Qualifications Required:
• High degree of fluency in English and Japanese (read, write and speak)
• A bachelor’s degree in a science/health related field (e.g., Biology, Nursing, Biomedical
or Veterinary Sciences) is required.
• 2-3 years experience in clinical/scientific research, nursing, or medical
devices/pharmaceutical industry preferred.
• Minimum of one year of clinical monitoring experience is preferred.
• Project management and interventional cardiology experience (as a nurse, technician,
sales representative, fellow or physician , etc.) is preferred.
Other specific qualifications include:
• Solid understanding of Japanese business culture and conduct.
• Demonstrated knowledge of GCP, ICH and Japanese MHLW guidelines on conducting
research.
• Demonstrated use of good communication skills, command of medical terminology and of
the application of scientific/medical and clinical concepts used to conduct clinical trials
• Self motivated and dynamic, requires minimum supervision
• Demonstrated attention to detail.
• Proficiency with basic computer skills Microsoft Office Suite, including Word, Excel,
Outlook, as well as use of internet, etc.
Additional skills preferred include:
Previous research experience including some or all of the following:
• Assisting sites and clinical trial sponsors with Institutional Review Board (IRB) submissions.
• Protocol design and development.
• Project management.
• Database construction and data entry.
• Compilation of interim and final clinical trial reports.
Expected Travel:
Extensive travel, reaching 60-80% of the time, is expected. Travel will primarily be in Japan, but may include other destinations in the Asia-Pacific region.