Clinical Research Associate II

4 weeks ago


Québec, Quebec, Canada Syneos Health Full time

About the Role

We are seeking a highly skilled Clinical Research Associate II to join our team at Syneos Health. As a Clinical Research Associate II, you will be responsible for performing site qualification, site initiation, interim monitoring, site management and close-out visits to ensure regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.

Key Responsibilities

  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
  • Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
  • Performs investigational product (IP) inventory, reconciliation and reviews storage and security.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan.
  • Supports subject/patient recruitment, retention and awareness strategies.

Requirements

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience.
  • 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.

About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Why Join Us

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.

We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.



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