30 Jul
|
Syneos Health
|
Toronto
30 Jul
Syneos Health
Toronto
Updated: June 17, 2026
Location: Toronto, ON, Canada
Job ID:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address up-to-date market realities.
Job Responsibilities
Perform site qualification, site initiation, interim monitoring, site management and close‑out visits (on‑site or remotely) ensuring regulatory, ICH‑GCP, Valuable Pharmacoepidemiology Practice (GPP) and protocol compliance.
Verify informed consent processes and safeguard patient confidentiality.
Conduct source document reviews, verify CRF data accuracy, resolve queries and drive resolution to closure.
Perform investigational product inventory, reconciliation, and storage/security checks.
Review and reconcile Investigator Site File (ISF) with Trial Master File (TMF) and ensure archiving requirements are met.
Document activities via letters, reports, logs, and other required project documents.
Manage site‑level activities, communications and project timelines, adapting to changing priorities.
Act as liaison with site personnel and, where applicable,
collaborate with Central Monitoring Associate.
Prepare for and attend investigator and sponsor meetings; lead clinical monitoring project staff meetings.
Provide guidance toward audit readiness and support audit preparation.
Mentor junior CRAs and provide training, as assigned.
Support real‑world late‑phase (RWLP) studies: site support, chart abstraction, operational efficiencies, and regulatory collaboration.
Qualifications
Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience.
Knowledge of Valuable Clinical Practice/ICH Guidelines and applicable regulatory requirements.
Good computer skills and willingness to embrace new technologies.
Excellent communication, presentation and interpersonal skills with basic critical‑thinking ability.
Ability to travel up to 75% of the time.
Equal Employment Opportunity
We are a diverse and inclusive employer, committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations to enable applicants to perform essential job functions.
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📌 Clinical Research Associate Canada Toronto
🏢 Syneos Health
📍 Toronto