Senior Clinical Research Associate
New
J
JobgetherClinical research
Based in CanadaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Full professional proficiency in both English and French is essential.
- Required Skills
- Microsoft Office
Requirements
- Have a college or university degree in Life Sciences, or an equivalent combination of education, training, and relevant experience.
- Have demonstrated independent on-site clinical monitoring experience.
- Have experience conducting different types of monitoring visits for Phase II and/or Phase III clinical studies.
- Have full professional proficiency in both English and French.
- Be proficient with Microsoft Office applications.
- Be able to plan and organize work and manage multiple priorities in a dynamic team environment.
- Be willing and able to travel regularly for on-site monitoring activities.
- Have a valid driver's license.
- Oncology clinical research experience is considered an asset.
Responsibilities
- Conduct and document Site Initiation Visits, Routine Monitoring Visits, and Close-Out Visits at clinical research sites.
- Review Case Report Forms and source documents, resolve queries, and ensure data quality and protocol compliance.
- Manage communication with assigned clinical sites throughout the study lifecycle.
- Coordinate with in-house support functions and external vendors involved in study activities.
- Update internal project teams on site performance, study progress, and emerging issues.
- Participate in feasibility activities to assess potential research sites and support study planning.
- Assist regulatory teams with preparing documentation for study submissions.
- Prepare for and participate in clinical audits and regulatory inspections.
- Follow applicable protocols, procedures, and regulatory requirements.
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