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We are a private, newly created, and non-profit Foundation linked to the Hospital Clinic de Barcelona, dedicated to strengthening people's health and improving citizens' quality of life.
We’re hiring a Clinical Trial Assistant to join the Barcelona Clinical Coordinating Center (BCCC), an academic Contract Research Organization (CRO) based in Barcelona. This is a great opportunity.
Responsibilities :
* Assist Clinical Research Associates (CRAs) and the Regulatory and Start-Up (RSU) team.
* Collect and archive site information and documents during startup.
* Assist in preparing submission packages for Ethics Committees (ECs) and Health Authorities (HAs), including initial submissions and substantial amendments, and handle submissions to ECs and HAs.
* Assist in preparing study- and site-specific materials following relevant SOPs.
* Assist with Clinical Trial Agreement preparation, review, and signatures.
* Prepare and maintain Investigator Site Files (ISF) and Trial Master Files (TMF).
* Assist with periodic audits and quality reviews of trial documentation.
* Provide general administrative support to the Project Manager and Coordinating Monitor.
* Coordinate the shipment and tracking of study materials such as paper ISF, Case Report Forms (CRFs), and lab supplies.
* Assist in coordinating investigator payments.
Requirements :
* Baccalaureate, higher vocational training in administration, or a university degree in sciences (preferably life sciences, medicine, or nursing).
* More than 1 year of experience in clinical trial administration within research settings (CRO, Pharma Industry, cooperative research groups, etc.).
* Strong written and verbal communication skills, with a good command of English.
* Computer literacy : working knowledge of Microsoft Word, Excel, and Outlook.
* Effective time management and organizational skills.
Valuable :
* Knowledge of applicable regulatory requirements, GCP, and ICH guidelines.
* Experience with clinical database applications for eTMF and CTMS.
Working conditions :
* Full-time position.
* Offices located in the center of Barcelona.
* Competitive salary range.
* Starting in June-July 2025.
* Benefits Club.
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Research, Analyst, and Information Technology
* Research Services
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