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Clinical Trial Associate Madrid Spain,  


Posted on : 08 March 2017

Project Description

Req #: 17000339 Location: Madrid, M ES Job Category: Clinical Development Work Location: Madrid, Spain Paseo Recoletos 37-39 Madrid 28004 Organization: Celgene Spain Division S. L. Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Individual Contributor Travel: No Description Purpose: Under the direction of Clinical Research Associate director, this individual is responsible for providing in house support and assistance to assigned Study Teams and management staff. The CCTA will provide support to the Study Team during start-up, maintenance and close-out of clinical studies.   Responsibilities include, but are not limited to: " Fulfill all responsibilities in accordance with Celgene SOPs / WPs and policies. " Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory requirements. " Participate in and contribute to Clinical Research meetings, study related meetings, training activities and crossfunctional activities as appropriate. " Contribute to general departmental administration and the development and continuous improvement of departmental procedures. " Maintain and facilitate effective and productive communication and working relationships with all members of the department and staff in other functions. " Take personal responsibility for the quality of work, meeting required quality and performance standards and completing all assigned tasks in the most efficient and effective manner. " Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research Manager. " Keep Celgene Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate. " Design and maintain contracts & administrative tracking tools. " Support the production, coordination, completeness and accuracy of EC submissions in order to guarantee Celgene studies are submitted and approved in a timely fashion (for studies monitored in house). " Customize contracts to local requirements as applicable. " Support/Perform Research Contract negotiations (in English & local language, where appropriate) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and Celgene s Legal Group, to ensure local Start Up timelines are adhered to. " Track Site payments to ensure timely payments are reflective of the contract s schedule. " Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks and logistical support related to R&D Studies. " Manage study material and study supplies, as applicable. " File and maintain the study administrative files locally and send original documents to central TMF. When applicable, ensure electronic filing. " Organize local Investigator Meetings, including agendas and minute production. " Liaise closely with the CRAs, Study Managers team and CTAs. " May conduct data query resolution and SAE information collection via facsimile, mail and telephone. " Manage local translators & printers for required local documents. " Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams. These might be single documents or packages and may be safety [submissions, safety letters (SUSARs), Investigator

Locations

Madrid M ES

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