Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.
We offer individualized solutions that are tailored to the specific needs of our sponsors. We work as integrated teams functioning with maximum transparency throughout each study, making sure that the sponsor is kept up to date on all study parameters and progress. We are dedicated to the highest standards of quality, with a special focus on the therapeutic areas oncology, immunology and CNS, based on experience and expertise.
Responsibilities

Ensure that the conduct of the study is in compliance with the currently approved study protocol/amendment(s), with ICH GCP, SOPs, and any applicable regulatory requirements in the assigned countries
conduct any kind of on-site monitoring visits (pre-study, initiation, routine monitoring, site closure)
review of and/or input to the study protocol, CRF and validation tools
preparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documents
preparation of submissions to Independent Ethics Committees (central and local) and to Competent Authorities
assisting of Investigator and Institution contracts, negotiating budgets and arranging site payments
query management in cooperation with the Clinical Data Management Team
assisting sites and the study team in managing contacts to external service providers such as central laboratories
participation in feasibility studies and Investigator selection
Responsibility for Site Management.

Experience required

At least 2 years previous experience as a Clinical Research Associate
University degree in sciences or related fields; and experience and knowledge of clinical trials and regulations
Advanced English
At least 2 years previous experience as a Clinical Research Associate
Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements

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