Clinical Research Associate Ii Or Senior
hace 1 semana
('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 at least 2 years of experience to join our amazing team in Spain. The ideal candidate has performed typical CRA duties and enjoys working as part of a small and vibrant team.
Therapeutic areas:
Neurology and Oncology.
Experience with any other TAs would be highly advantageous.
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 countriesConduct on-site monitoring visits, including pre-study, initiation, routine monitoring, site closureReview of and/or input to the study protocol, CRF and validation toolsPreparation and/or review of Monitoring Guidelines, CRF Completion Guideline, patient information documentsSupport the Regulatory Affairs team with regards tosubmissions to Independent Ethics Committees (central and local) and to Competent AuthoritiesAssisting of Investigator and Institution contracts, negotiating budgets and arranging site paymentsQuery management in cooperation with the Clinical Data Management TeamAssisting sites and the study team in managing contacts to external service providers such as central laboratoriesParticipation in feasibility studies and Investigator selectionResponsibility for Site ManagementExperience & Qualifications:
- University degree in sciences or related fields, as well as experience & knowledge of clinical trials and regulations
- Advanced English and fluent Spanish
- At least 2 years' experience as an independent clinical trial monitor/ CRA, preferably in a pharmaceutical company or CRO
- Sound knowledge of relevant guidelines (e.g. ICH GCP) and regulatory requirements
- Travel availability across SpainAt 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.#J-18808-Ljbffr
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Majadahonda, Madrid, España Linical Europe A tiempo completoLinical 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...
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