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:
We're looking for a CRA with regulatory experience in clinical trial submissions within the UK. The ideal candidate has regulatory expertise and also enjoys carrying out typical CRA duties whilst conducting a low number of monitoring visits per month.
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 & Qualifications:
- University degree in sciences or related fields, as well as experience & knowledge of clinical trials and regulations
- Advanced English
- 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
- Strong team player combining communication and organizational skills
- Travel availability across the UK
At Linical, we embrace the opportunities and possibilities that are held by diversity, equal opportunity and inclusion. We value bringing together individuals from diverse backgrounds regardless of race, disability, ethnicity, gender, sexual orientation or any other legally protected characteristic. Linical will consider all candidates that match with the requirements of the position, promoting diversity and equal opportunity for all.