Cra Ii

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.

Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.

**Role summary**:

- site monitoring visits across Spain.

At Linical, our CRAs are part of a warm environment, having their ideas heard by the management team and their peers. They're supported from day 1, experiencing a well planned induction & on-boarding process which allows them time to get to know the SOPs and study details in the appropriate manner. They can also count on the support of their colleagues and enjoy a great work life
- balance.

Our CRAs report great satisfaction levels and feel like they can have a vibrant life outside of work.

**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 on-site monitoring visits, including pre-study, initiation, routine monitoring, and 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 & Qualifications**:

- University degree in sciences or related fields, as well as experience & knowledge of clinical trials and regulations
- Advanced English & fluent Italian
- At least 2 years of experience within Clinical Monitoring in a pharmaceutical company or a CRO
- Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements
- Travel availability across Spain

Equal opportunities employer: