Clinical Research Associate II

5 giorni fa


Milano, Lombardia, Italia PSI CRO A tempo pieno
Job Title: Clinical Research Associate II

At PSI CRO, we are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate, you will play a critical role in the success of our clinical studies, working closely with our clients and internal teams to ensure the highest quality standards are met.

Key Responsibilities:
  • Conduct and report onsite monitoring visits, ensuring compliance with regulatory requirements and study protocols.
  • Be involved in study startup, including site selection, feasibility assessments, and initiation visits.
  • Perform CRF review, source document verification, and query resolution to ensure data accuracy and integrity.
  • Manage site communication and relationships, ensuring timely and effective issue resolution.
  • Collaborate with internal project teams to ensure study progress and milestones are met.
  • Participate in feasibility research and support regulatory teams in preparing documents for study submissions.
  • Prepare for and participate in audits and inspections, ensuring compliance with regulatory requirements.
Qualifications:
  • University/College degree in Life Sciences or an equivalent combination of education, training, and experience.
  • At least 2 years of independent onsite 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.
Why Join PSI CRO?
  • We are 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, with a focus on employee well-being and development.
  • We offer extensive onboarding and mentorship programs, profound therapeutic area trainings, and interactive soft-skills trainings.
  • Our CRAs have the 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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