7 дней назад
Clinical Research Associate, Multi-Sponsor, Belgium
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Research Associate, Multi-Sponsor, Belgium (Clinical Research): Monitoring and managing clinical trial sites across multiple sponsors, with an accent on GCP/ICH compliance, recruitment tracking, regulatory submissions, and trial documentation. Focus on conducting site visits, resolving data queries, maintaining TMF and ISF records, and coordinating study execution with sites and project teams.
Location: Brussels, Brussels-Capital Region, Belgium; Belgium-based
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits in line with the study protocol, GCP, ICH guidelines, and regulatory requirements.
- Support subject recruitment planning, tracking, and enrollment activities across assigned sites.
- Deliver protocol and study training and maintain regular communication with sites regarding expectations, issues, and project progress.
- Assess site quality and compliance, escalate issues, and manage corrective action plans.
- Track regulatory submissions, approvals, CRF completion, data queries, and study documentation, including TMF and ISF records.
- Prepare monitoring reports, follow-up letters, and other required documentation while collaborating with study team members.
Requirements
- University degree in a scientific or healthcare discipline.
- At least 2 years of experience as a Clinical Research Associate.
- Excellent command of Dutch, French, and English; Belgium-based.
- Strong organizational, time-management, problem-solving, and relationship-management skills.
- Good computer skills, including MS Office.
- Flexibility to travel and a Class B driver’s license.
Culture & Benefits
- Career growth resources and programs supporting therapeutic knowledge development.
- Flexible work schedules supported by leadership.
- International working environment in a stable and reputable organization.
- Company car, mobile phone, and an attractive benefits package.
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