CRA / Clinical Research Associate

Region Milano
Job category Pharmaceutical, Healthcare
Language requirements Italian (C2) and English (C1)
For graduates no
Salary by agreement

Contact our recruiter!

  • Michaela Özden

Our client is a CRO organization with specialization in very complex clinical studies. For their Italian office in Milan, we are looking for certified Clinical Research Associate (m/f/d).

Description and responsibilities

  • Serving as a main contact for assigned investigative sites
  • Completing site selection and pre-study activities to identify and evaluate potential investigators
  • Assisting in site evaluation and reporting to Study Manager
  • Managing investigative site activity for multiple protocols / indications and providing ongoing updates of site status to Study Manager, ensuring compliance and understanding of study requirements by site staff
  • Assisting with study start-up activities: collecting, reviewing and tracking regulatory site documents, assisting in regulatory submission processes to Ethic Committees and Competent Authority; and contract and budget negotiation
  • Participating in study-specific training and attending Investigator meetings
  • Completing monitoring visits and routing monitoring activities to ensure the integrity completeness and accuracy of clinical data and appropriate follow-up of study procedures, including source document verification and SAE reporting in accordance with the Project Plan, Study protocol, GCP/ICH Guidelines and applicable regulations
  • Anticipating / identifying site issues and study deviations and implementing corrective actions and a proper escalation to Study Manager, as necessary
  • Ensuring proper storage, dispensation and accountability of all investigational product(s) and trial-related material
  • Attending global project team teleconferences and providing ongoing updates of site status to Study Manager; maintaining CTI / Sponsor project tracking systems, as required
  • Completing assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements

Your profile

  • Bachelor’s or Master’s Degree in allied health fields, such as Health / Natural sciences, Pharmacy, or Nursing
  • Research Nurse RN or study coordinator or 3-year Nursing Diploma with at least 2 years of clinical nursing experience
  • 2+ years of prior clinical monitoring experience
  • Knowledge in applicable regulatory requirements in Italy
  • Proficient in the use of laptop computer and software systems (MS-Office, eTMF, CTMS, etc.)
  • Excellent communication, presentation and interpersonal skills in English
  • Reliability and a good sense of team working


  • Very complex position with clinical trial as well as regulatory affairs tasks
  • Independent way of working
  • A nice and motivated team
  • Diverse tasks with an international focus
  • Unlimited contract
  • Flexible working hours
  • Attractive Bonus System
Our website uses cookies, as almost all websites do, to help provide you with the best experience we can. By using this site you agree to it.
Close More information