Original listing text, shown exactly as published by the company.
About the Role(s)
- 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.
Qualifications (may vary depending on role needs)
- CRA I - minimum 1 year experience + Honours Bachelor Degree
- CRA II - Minimum 2 years experience + Honours Bachelor Degree
- Sr. CRA - Minimum 3 years experience + Honours Bachelor Degree
Compensation/Total Rewards
- Compensation may vary depending on the role seniority, geographic location, and candidate experience.
- All full-time, permanent roles will include a base salary + elgibility for performance-based bonus, as well as a variety of health, dental, RRSP matching, and more!
- If contacted for an initial call, a member of our TA team will be happy to share more.
