Clinical Research Associate II

4 days ago


Québec, Quebec, Canada Parexel International Full time

Job Overview

Parexel International is seeking a highly motivated and experienced Clinical Research Associate II to join our team. As a Senior CRA, you will play a critical role in the success of our clinical trials by ensuring the smooth execution of study protocols.

About the Role

The successful candidate will be responsible for coordinating with site care partners to transition site management accountability at the point of site initiation/activation. You will work closely with investigative sites to ensure compliance with ICH GCP and local requirements, and provide guidance on data integrity, data quality, and query resolution techniques.

Key Responsibilities

  • Maintain a thorough knowledge of assigned protocols and ensure site monitoring readiness in anticipation of first subject first visit
  • Support activities related to site initiation, including training, collection of necessary documentation, and access to systems
  • Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient
  • Conduct monitoring activities using different methods, e.g., both on-site and remote, where allowed by country regulations
  • Manage reporting of protocol deviations and follow-up

Requirements

  • A minimum of 3 years of direct clinical monitoring experience in a CRO or pharma setting
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Excellent communication, presentation, and interpersonal skills
  • Ability to manage required travel of up to 75% on a regular basis
  • Demonstrated networking and relationship building skills

About Us

Parexel International is a leading global biopharmaceutical services company that provides end-to-end solutions for drug and device development. We are committed to helping our clients achieve their goals through innovative, flexible, and cost-effective solutions.



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