CRA / Clinical Research Associate

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

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  • 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

Benefits

  • 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
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