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Clinical Research Associate II
2 months ago
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 play a critical role in the success of our clinical trials by ensuring the quality and integrity of the data collected.
Key Responsibilities- Conduct site evaluation visits to assess the capability of potential investigators to manage and conduct clinical studies.
- Collaborate with the Investigator Site Support Center (ISSC) department to coordinate activities with the site in preparation for the initiation of the study.
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF.
- Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
- Ensure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
- 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.
- BS/BA/BSc (or equivalent) in one of the life sciences or health care 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
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.
