6 дней назад
Clinical Research Associate II - Sponsor dedicated - Belgium - Home based (m/w/d)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Clinical Research Associate II - Sponsor dedicated - Belgium - Home based (m/w/d) (Clinical Research/GCP): Managing site monitoring and clinical study execution for a sponsor-dedicated model in Belgium with an accent on GCP/ICH compliance, recruitment tracking, regulatory submissions, and trial documentation. Focus on conducting monitoring visits, resolving site and data issues, maintaining TMF and ISF documentation, and coordinating with investigators and cross-functional study teams.
Location: Home based in Belgium; the role is listed in Zaventem.
Company
is a global provider of clinical research services, healthcare intelligence, data solutions, and commercial insights for the life sciences and healthcare industries.
What you will do
- Conduct site selection, initiation, monitoring, and close-out visits in line with the contracted scope, GCP, ICH, and regulatory requirements.
- Support site recruitment plans, track enrollment, and manage protocol and study training for assigned sites.
- Assess site quality, protocol compliance, and regulatory adherence, escalating issues when appropriate.
- Track regulatory submissions, approvals, CRF completion, data queries, and study progress.
- Maintain TMF and ISF documentation and prepare monitoring reports, follow-up letters, and action plans.
- Collaborate with investigators, medical staff, project managers, study coordinators, and global cross-functional teams.
Requirements
- University degree in a scientific or healthcare discipline.
- At least 18 months of independent, on-site monitoring experience as a CRA in a CRO or pharmaceutical environment.
- Excellent written and spoken Dutch, French, and English.
- Knowledge of clinical research regulations, including GCP and ICH guidelines.
- Strong organizational, problem-solving, interpersonal, and cross-cultural communication skills.
- Ability to collaborate with Belgian investigators, medical staff, project managers, and local study coordinators.
Culture & Benefits
- Access to career development resources, training, and advancement opportunities.
- Dedicated learning and development programs to expand therapeutic knowledge.
- Flexible work arrangements supporting professional and personal commitments.
- Company car, mobile phone, and a rewards and benefits package.
- Supportive culture within a global organization.
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