CRA II / Senior CRA – Sponsor Dedicated, Oncology, Bilingual – French, English

Posted 21 hours ago

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About the role

  • CRA II/Sr CRA for Oncology conducting site qualifications, management, and monitoring for a leading life sciences organization. Home-based position in Quebec, Canada.

Responsibilities

  • Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
  • Demonstrates diligence in protecting the confidentiality of each subject/patient.
  • 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.

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
  • Must demonstrate good computer skills and be able to embrace new technologies
  • Excellent communication, presentation and interpersonal skills.
  • Basic level of critical thinking skills expected.
  • Ability to manage required travel of up to 75% on a regular basis.

Benefits

  • 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 building an inclusive culture – where you can authentically be yourself.

Job title

Job type

Full Time

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Google Cloud Platform

Location requirements

RemoteCanada

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