Clinical Research Associate – Canada

Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating clinical research and improving patient outcomes.

Responsibilities

- Perform site qualification, initiation, interim monitoring, site management, and close‑out visits (on‑site or remote) ensuring compliance with regulatory, ICH‑GCP, Good Pharmacoepidemiology Practice (GPP) and protocol requirements.
- Evaluate overall site performance and staff, develop action plans, and promptly report serious issues to the project team.
- Verify informed consent processes, protect subject confidentiality, and assess factors affecting subject safety and data integrity.
- Conduct source document review, verify CRF data accuracy, resolve queries, and ensure electronic data capture compliance.
- Perform investigational product inventory, reconciliation, and ensure proper dispensing and storage according to protocol.
- Maintain and reconcile Investigator Site File (ISF) and Trial Master File (TMF) for accuracy and completeness.
- Document activities through letters, reports, and logs, and support subject recruitment, retention, and awareness strategies.
- Manage project scope, budgets, and timelines; adapt quickly to changing priorities to meet objectives.
- Act as primary liaison with site personnel and ensure training and compliance with applicable requirements.
- Prepare for and attend investigator and sponsor meetings, and lead or participate in global monitoring/project staff meetings.
- Guide audit readiness,



support audit preparations, and provide training or mentorship to junior CRAs.
- Assist in real‑world late‑phase activities, including site support, chart abstraction, data collection, regulatory collaboration, and process improvement.

Qualifications

- Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
- Knowledge of ICH GCP, Positive Clinical Practice, and other applicable regulatory requirements.
- Proficient computer skills and willingness to learn new technologies.
- Excellent communication, presentation, and interpersonal skills; basic critical‑thinking ability.
- Ability to travel up to 75% of the time on a regular basis.

Additional Information

Tasks, duties, and responsibilities as listed herein are not exhaustive. The Company may assign additional tasks, duties, or job responsibilities at its sole discretion. Equivalent experience, skills, and/or education may also be considered. This position and any related responsibilities comply with all applicable laws and regulations, including the EU Equality Directive and the Americans with Disabilities Act. Reasonable accommodations are available to qualified applicants.

Summary

Clinical Monitoring/CRA professionals monitor clinical research studies, ensuring trials meet accepted clinical practices through on‑site and remote monitoring, and by developing tools, procedures, and processes to ensure quality and compliance.

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📌 Clinical Research Associate - Canada (Toronto)
🏢 Syneos Health
📍 Toronto