Senior Project Specialist (Clinical Trial Assistant)
New
J
JobgetherClinical Research
CanadaFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- English proficiency required; French proficiency preferred.
- Experience
- 2–3+ years
Requirements
- 2–3+ years of experience working as a Clinical Trial Assistant (CTA) within a clinical research environment.
- Demonstrated direct experience supporting clinical trials and managing clinical documentation.
- Hands-on experience with Veeva Vault Trial Master File (TMF) management is required.
- Strong knowledge of clinical trial documentation processes, study startup activities, and regulatory requirements.
- Experience tracking study milestones, operational metrics, enrollment activities, and project deliverables.
- Excellent organizational skills with the ability to manage large volumes of information accurately.
- Strong written and verbal communication skills with the ability to collaborate across multiple stakeholder groups.
- Ability to work independently, prioritize tasks, and manage deadlines in a remote setting.
- English proficiency required; French proficiency preferred, with the ability to review French-language documents.
Responsibilities
- Manage, organize, reconcile, and maintain Trial Master Files (TMF) within Veeva Vault, ensuring completeness, accuracy, and inspection readiness.
- Collect, review, track, and archive essential regulatory and clinical study documentation according to established requirements.
- Support study startup activities, including document collection, tracking, site activation coordination, and regulatory submission support.
- Monitor study timelines, milestones, enrollment activities, deliverables, and operational metrics.
- Coordinate project meetings by preparing agendas, recording minutes, tracking action items, and supporting follow-up activities.
- Maintain project trackers, status reports, KPIs, study metrics, and operational reporting documentation.
- Ensure clinical trial documentation follows SOPs, Good Clinical Practice (GCP), regulatory standards, and quality requirements.
- Support audit and inspection readiness activities, including quality reviews, corrective action follow-up, and document archiving.
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