4 часа назад
Senior Clinical Research Associate (Canada)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Associate (Canada) (Clinical Trials): Conducting independent onsite monitoring and source verification for Phase 1 clinical studies with an accent on regulatory compliance, investigator documentation, and data quality. Focus on resolving data discrepancies, managing site contracts and budgets, and ensuring reportable events and non-compliance issues are properly addressed.
Location: Must be located in Ontario or Quebec, Canada; the role includes onsite monitoring of clinical research sites.
Company
provides functional clinical research services to biotech, medtech, and specialty pharmaceutical companies developing medicines, devices, and diagnostics.
What you will do
- Conduct source verification by comparing case report forms with source documents and reviewing informed consent, regulatory, and device accountability records.
- Investigate and resolve data discrepancies, document visit reports, and escalate issues when required.
- Identify, document, and report non-compliance and reportable events according to protocols, regulations, ICH/GCP, and ISO 14155 requirements.
- Manage study contracts and collect, review, and approve investigator and site documentation.
- Perform budget negotiations with clinical trial sites.
Requirements
- Bachelor's degree or international equivalent, preferably in a clinical, biological, scientific, or health-related field, or an equivalent combination of education, training, and experience.
- 5–7 years of practical experience conducting independent onsite monitoring of clinical research sites and site management activities, or proven experience performing the primary job functions.
- Experience with Phase 1 studies.
- Fluent English and French are required.
- Must be located in Ontario or Quebec, Canada.
- Strong analytical and organizational skills, with the ability to work independently and manage multiple projects in a fast-paced environment.
Culture & Benefits
- Part-time six-month contract with potential for extension.
- Flexible work practices intended to support professional growth and work-life balance.
- Opportunity to contribute to clinical research supporting new medicines, devices, and diagnostics.
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