Cra - Usa
Vor 4 Tagen
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 American arm is headquartered in Florida. Its European Headquarters are located in Frankfurt, Germany, with a substantial presence in Paris and Madrid also. Its geographic footprint facilitates a significant presence in North America, the leading Western European markets as well as Asia, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.
**Role summary**:
This is a fully remote position, offered on a permanent basis.
**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
- 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
- Fluent English skills
- At least 1 year 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 the US (70% travel)
- Equal opportunities employer:_
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