Clinical Research Associate monitoring Canadian clinical trials for Parexel, a global clinical research organization. Managing site relationships, compliance, data quality, and study delivery.
About the role
- Senior Clinical Research Associate monitoring investigator sites and ensuring GCP-compliant clinical trial execution. Supporting patient safety, recruitment, data quality, and study close-out for Parexel.
Responsibilities
- Manage investigator site relationships and assigned clinical trial site activities from site activation through database lock and close-out
- Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices (GCP), and Sponsor standards
- Serve as primary point of contact for assigned investigator sites and coordinate with the Site Care Partner and study team
- Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure
- Provide site personnel coaching, training, protocol training, and recruitment support
- Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit
- Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply management, study progress, and metrics
- Identify and resolve site issues, develop corrective and preventive actions, and resolve data queries
- Ensure oversight of investigational product receipt, handling, accounting, storage, and destruction
- Support database release and undertake unblinded monitor responsibilities when appropriate
- Maintain product, protocol, and therapy-area knowledge and provide clinical guidance to investigators
- Drive Quality Event remediation and support audit observation CAPA development and checks
Requirements
- Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
- Minimum 3 years relevant experience in clinical research site monitoring
- Must be fluent in English and in the native language(s) of the country they will work in
- Ability to travel 60-80%
- Valid driver’s license and passport required
- Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
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