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Regulations

In compliance with Organic Law 15/1999, of 13 December, under the Personal Data Protection Act, we inform you that data collected will form part of an automated file, under the ownership of BARCELONA ACTIVE SPM S.A., with registered office at 162-164 Calle Llacuna, Barcelona, with the aim of managing enrollments and of informing of the company's activities and services within its field of action. You will be able to exercise access rights, rectification, cancel cancellation and/or opposition via written communication to the Legal Services of BARCELONA ACTIVE SPM S.A. at the aforementioned address.

 
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Other denominations

Clinical Research Associate (CRA)

Description

The process for the approval of a new medication for human use is complex and time consuming. After pre-clinical investigation (in vitro and in animals), a new drug is tested on humans during a clinical trial using a methodology that is divided into three phases, until reaching the stage of post-marketing drug study and follow-up, or fourth phase. The whole process normally involves, at least, about 3,000 people, lasts between five and ten years (although this can vary a lot), and have a total cost of between 300 and 500 million euros. Registration requires presenting all the scientific documentation, including trial protocols and the results obtained. The clinical trial monitor or clinical research associate leads this project and is responsible for the clinical practices of a trial to approve a drug product, and ensures compliance with the requirements of the regulatory agency. They work in pharmaceutical companies or CRO (Contract Research Organizations) that offer to perform clinical trials for the pharmaceutical industry. Clinical trials usually take place in several centers and in different countries.

Tasks

  • Participate in the development of the general clinical plan, supervise the development and review of clinical trial protocols that have to fulfill the requirements of regulatory agencies, and collaborate in the organization of statistical analysis plans.
  • Monitor clinical trials, coordinate the scientific follow-up, centralize all the data and inform all investigators about the evolution of the trial. Work in accordance with GCP standards (Good Clinical Practices).
  • Participate in the identification and selection of the national and international clinical research centers that must fulfill certain rating and experience levels.
  • Provide clinical investigators with all the clinical, pharmacological and toxicological information about the investigational product to ensure correct planning and performance of the trial, as well as all vital information that becomes available during the trial.
  • Ensure the traceability of the medication delivered, collection of any unused medication and any related incidents.
  • Organize meetings with all participants from clinics and regulatory and research agencies, to ensure follow-up of the clinical trial, identify problems and solve any deviations from the protocol.
  • Ensure correct transmission of clinical data to the regulatory agency.
  • Follow-up and control the collaborators designated to each project.
  • Prepare and update the trial master file under GCP regulations.

Quick access and copyright:

Centre per al desenvolupament professional Porta22
Convent de Sant Agustí
Ca n'Andalet

Barcelona Treball (Porta22)
+34 934 019 899
bcn.cat/treball

Barcelona Activa Headquarters
Llacuna, 162-164
08018 Barcelona
+34 934 019 777
bcn.cat/barcelonactiva

Generalitat de Catalunya
Unió Europea FEDER
Unió Europea FSE