**Job Title:** Site-Clinical Study Coordinator (Site-CSC)
**Location:** Belgium - Flemish Brabant - Zaventem
**Category:** Medical and Clinical Affairs
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### **About the Role**
The **Site-Clinical Study Coordinator (Site-CSC)** will provide administrative support to the study team throughout the clinical study process. This role involves ensuring timely filing of study documents, creating and shipping patient and regulatory binders, and assisting with study materials. Working closely with the Site-inhouse CRA (Site-ICRA), the Site-CSC contributes to maintaining site audit readiness.
---
### **Key Responsibilities**
- **Regulatory Binder Management**: Create and prepare the Study Site Regulatory Binder and Patient Binder, ensuring they contain all study-approved documents.
- **Quality Checks**: Perform quality checks on site-specific regulatory and patient binders, ensuring all documentation is accurate.
- **Document Handling**: Organize and file site and sponsor correspondence, EC submission packages, and document uploads into the Trial Master File.
- **Audit Readiness**: Assist with maintaining site audit readiness by tracking submission and correspondence related to essential site documents.
- **Site Communication**: Act as the point of contact within the Site-CSC team for the assigned Business Unit and assist with sending study communication, such as newsletters to sites.
- **Shipment Coordination**: Support and track the shipment of project-related equipment and data between sites, the sponsor, and core labs.
- **Study Support**: Attend study-related meetings and contribute to the overall smooth operation of the clinical study.
---
### **Qualifications**
- **Education**: High school diploma/secondary school degree.
- **Experience**: One year of clinical research experience or related device/pharmaceutical experience, or relevant clinical experience in a hospital environment.
- **Skills**:
- Proficient in Microsoft Word, Excel, or similar software.
- Strong organizational skills and attention to detail.
- Strong verbal and written communication skills, including fluency in English.
- Ability to handle sensitive and confidential information with discretion.
- Capable of working independently when necessary and maintaining regular attendance.
---
### **Our Offer**
- Competitive salary and comprehensive benefits package.
- Opportunities for professional growth and development.
- A collaborative and innovative work environment.
- Access to health and wellness programs, work-life balance initiatives, and employee assistance programs.
- Inclusive company culture with continuous learning and development opportunities.
---
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