Clinical Research Associate II

7 days ago

Kirkland, Quebec, Canada IQVIA Full time
Job Summary

IQVIA is seeking a highly skilled Clinical Research Associate II to join our team in Eastern Canada. As a Clinical Research Associate II, you will be responsible for monitoring and managing clinical trials in the oncology field. This is an exciting opportunity to work with a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry.

Key Responsibilities
  • Participate in the preparation and execution of Phase I-IV clinical trials.
  • Oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close-out visits to sites.
  • Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
  • Work closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
  • Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF.
  • Monitor and manage clinical trials, ensuring compliance with Good Clinical Practices, investigator integrity, and compliance with all study procedures.
  • Document accountability, stability, and storage conditions of clinical trial materials as required by sponsor.
  • Review the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site source verification.
  • Perform study close-out visits per the study-specific Clinical Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items.
Requirements
  • BS/BA/BSc (or equivalent) in one of the life sciences or healthcare background (RPh, RN, etc.) and a minimum of two (2) years of monitoring/site management experience is required.
  • Must possess 2+ years of oncology and/or medical device experience.
  • Experience in monitoring and/or coordinating clinical trials required.
  • Must be able to travel domestically approximately 65%-85%.
  • Valid driver's license.
  • Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint and use of a laptop computer.
What We Offer

IQVIA is proud to be an equal opportunity employer and we are committed to creating a diverse and inclusive environment. We do not discriminate on the basis of any applicable prohibited ground of discrimination, including but not limited to race, religion, color, national origin, gender, sexual orientation, age, marital status, or disability. Accommodations for applicants with disabilities are available at all stages of the recruitment process upon request.

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