Clinical Research Associate - Italy

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 serving 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
• Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements