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Pharmaceutical, Biotechnology, Clinical Research, Contract Research Organization (CRO)

Clinical Research Associate II

RemoteRemoteFull TimePosted 4 days ago

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Required skills

  • North America
  • Phase II
  • Phase III
  • English
  • French
  • MS Office

Nice to have

  • study startup
  • feasibility research
  • regulatory submissions
  • therapeutic indications

Role summary

PSI is seeking a Clinical Research Associate II to conduct monitoring tasks for clinical studies across various therapeutic indications. Responsibilities include performing onsite monitoring visits, study startup activities, CRF review, source document verification, query resolution, and site communication. The role requires proficiency in English and French, MS Office applications, and involves planning, multitasking, and collaboration. This position offers an opportunity to develop expertise in clinical research within a leading Contract Research Organization.

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
  • 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

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

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.

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