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Clinical Research Associate II

🕒 11 days ago
Clinical MonitoringOnsite MonitoringStudy StartupCRF Review
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📜 Description

  • Conduct and report onsite monitoring visits.
  • Support study startup and feasibility research.
  • Review CRFs, verify source documents, and resolve queries.
  • Manage site communications and serve as a contact for internal support services and vendors.
  • Communicate study progress to internal project teams.
  • Support the regulatory team with study submission documents.

🛠️ Requirements

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience in France
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in oncology, hemophilia, infectious diseases, GI
  • Full working proficiency in English
  • 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
  • Your CV/resume must be submitted in English

✨ Benefits

  • Mentorship and training program.
  • Development opportunities across company departments.
  • Flexible working hours.
  • Home-office option and home-and-office work arrangement.
  • Onboarding and professional development training programs.
  • Positive team atmosphere.
  • 12 additional RTT leave days.
Full job description

Company Description

PSI is a leading Contract Research Organization with more than 22 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

  • 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

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience in France
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in oncology, hemophilia, infectious diseases, GI
  • Full working proficiency in English 
  • 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
  • Your CV/resume must be submitted in English

Additional Information

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

We offer:         

  • Big professional advancement opportunity within Clinical Operations with specific mentorship and training program
  • Development opportunities across PSI departments
  • Flexible working hours
  • Home-office option available, as well as combination of home and office work arrangement
  • Extensive onboarding trainings and professional development training programs
  • Highly developed company culture and positive team atmosphere
  • Additional leave days (12 days of RTT)
  • Please submit your CV/resume in English

 

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