Clinical Research Associate II

2 mesi fa

Milano, Lombardia, Italia PSI A tempo pieno

Job Title: Clinical Research Associate II

Job Summary:

We are seeking a highly skilled Clinical Research Associate II to join our team at PSI Italy. As a Clinical Research Associate, you will be responsible for conducting and reporting onsite monitoring visits, participating in study startup, and performing CRF review, source document verification, and query resolution.

Responsibilities:

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup
  • Perform CRF review, source document verification, and query resolution
  • Be responsible for site communication and management
  • Be a point of contact for in-house support services and vendors
  • Communicate with internal project teams regarding study progress
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions
  • Prepare for and participate in audits and inspections

Requirements:

  • University/College degree in Life Sciences or an equivalent combination of education, training & experience
  • At least 2 years of independent on-site monitoring experience in Italy
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in Oncology / Gastroenterology therapeutic areas is a strong advantage
  • Full working proficiency in English and Italian
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

About PSI:

  • PSI is a stable, privately-owned company, organically growing since 1995.
  • We have an excellent reputation in the industry, having won the CRO Leadership awards several years in a row.
  • Team collaboration is high on our agenda. Our aim is for employees to feel valued and heard in friendly and supportive teams.
  • We offer extensive onboarding and mentorship programs, profound therapeutic area trainings, interactive soft-skills trainings.
  • PSI CRAs have an opportunity to work with different Sponsors on a variety of therapeutic areas.

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

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