Clinical Research Associate (CRA)

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.

• 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.

Regulated training and graduates

• Grau: Farmàcia
• Grau: Medicina
• Grau: Biologia
• Grau: Bioquímica
• Grau: Biotecnologia
• Grau: Química

Complementary training

Other specific skills

Leadership: Level 2

Planning and organisation: Level 3

Strategic orientation: Level 2

Concern for order and quality: Level 4

Learning and use of knowledge: Level 2

Analytical thought: Level 2

Management

The organisation, administration and control of a company or entity are the main interests of people related to the management field. Activities included in this field of interest vary from effective resource management, feasibility analyses and solving business problems to the development of skills and fostering of motivation in relation to human resources. Knowledge regarding specific techniques of strategic administration and business management are required to carry out these activities.

Study manager

Medical writer

Pharmaceutical product manager

Drug development technician.

Pharmacoeconomics Manager

• Work hours

  The working day can be part- or full-time.

• Salary

  The gross salary ranges, on average, between 22.237 and 26.438euros a year, depending on the company and the candidate. Median: 24.247 euros annum gross.
  
  
  Source: Report "Observatory of Jobs and Salaries of the Labour Market. Barcelona Activa", elaborated by ICSA Grupo. April 2015.

• Professional category

  Middle management