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Posted 29 days ago

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Clinical Research Associate II

Saint-Maur-des-Fossés, IDF, FranceRemoteFull-time

AI Summary

A Clinical Research Associate II plans and conducts clinical study monitoring visits, performs source document verification and query resolution, supports study startup and feasibility research, and serves as a key site contact across therapeutic areas.

About this role

Clinical Research Associate II

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.

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

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)

 

Skills

Clinical MonitoringCRF ReviewEnglishFeasibility ResearchMS OfficeOn-site MonitoringQuery ResolutionRegulatory Document PreparationSource Document VerificationStudy Startup

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