Join our Talent Pool - Clinical Research Associates (Canada)

Clinical Research Associate I/II

• Support/conduct (as appropriate) site management through remote and supervised onsite visits (initiation, monitoring, and close-out) in compliance with SOPs, protocol, and GCP.
• Perform remote data and system reviews (EDC, CTMS, RBM, TMF) to ensure data quality, completeness, and regulatory compliance.
• Assist/lead (as appropriate) with query resolution, safety reviews, and adverse event follow-up throughout the study lifecycle.
• Support/conduct (as appropriate) site startup and activation activities, including investigator coordination, trial material delivery, and recruitment support.
• Maintain accurate, timely, and complete TMF documentation, requesting updates as required.
• Provide day-to-day operational support to Senior CRA, and Lead CRAs.
• Participate in training, study meetings, and CRA development activities, building competencies required for role progression.

Sr. Clinical Research Associate

As above, with the addition of the following:

• Act as subject matter expert, mentor, coach and/or provide performance feedback to manager for peers.
• Assist with selection, hiring, training, and supervision of CRAs as needed. Perform co-monitoring and training visits with CRAs.
• When required, act as the first escalation point for the resolution of site/patient issues or to address Sponsor concerns.
• May represent Director, Monitoring and Site Management or Manager, Clinical Site Management in BD initiatives with a site monitoring focus.
• May be assigned Lead CRA role and manage monitoring services for a group of projects and/or CRAs on large/complex project(s) including directing/guiding day to day activities and review/approval of monitoring reports.
• Oversee overall integrity of the study to promote positive working relationships with the site and staff.
• Ensure SOPs in place to optimize patient recruitment providing guidance to site teams of inclusion/exclusion criteria.