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Senior Clinical Research Associate

2 months ago


Montreal, Quebec, Canada PSI Full time

Job Overview

As a Senior Clinical Research Associate at PSI, you will play a vital role in ensuring the highest quality standards in clinical studies across various therapeutic indications.

You will:

  • Conduct and report on-site monitoring visits, ensuring compliance with regulatory requirements.
  • Perform comprehensive CRF review, source document verification, and query resolution to maintain data integrity.
  • Manage site communication and relationships, serving as a key point of contact for in-house support services and vendors.
  • Collaborate with internal project teams to provide regular study progress updates.
  • Participate in feasibility research to identify potential study sites and ensure smooth study execution.
  • Support the regulatory team in preparing documents for study submissions, ensuring compliance with regulatory requirements.
  • Prepare for and participate in audits and inspections, demonstrating PSI's commitment to quality and compliance.

Requirements

  • College/University degree in Life Sciences or an equivalent combination of education, training, and experience.
  • Independent on-site monitoring experience, with a strong track record of ensuring compliance and data integrity.
  • Experience in all types of monitoring visits in Phase II and/or III, with a focus on Oncology.
  • Full working proficiency in English and French is essential, with the ability to communicate effectively with global teams.
  • Proficiency in MS Office applications, with the ability to analyze and present data effectively.
  • Strong problem-solving skills, with the ability to work in a dynamic team environment and adapt to changing priorities.
  • Ability to travel, with a valid driver's license.

About PSI

PSI is a leading provider of clinical research services, dedicated to delivering high-quality results and exceptional customer service. As a Senior Clinical Research Associate, you will be part of a dynamic team that is passionate about advancing medical knowledge and improving patient outcomes.