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Posted 4 days ago

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Clinical Research Associate II

TorontoRemoteFull-time

AI Summary

Conducts onsite clinical monitoring visits for Phase II/III studies, managing site communication, CRF review, source document verification and query resolution. Supports study startup, feasibility and regulatory submission work.

About this role

PSI is a leading Contract Research Organization with more than 30 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 II 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 (if applicable)
  • 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 North America.
  • Experience in all types of monitoring visits in Phase II and/or III
  • Full working proficiency in English and French.
  • 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
  • Valid driver’s license

 

## 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.

Skills

Clinical MonitoringCRF ReviewEnglishFeasibility AssessmentFrenchMicrosoft OfficePhase II/III TrialsQuery ResolutionRegulatory SubmissionsSite ManagementSource Document VerificationStudy Startup

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