Clinical Research Associate, Multi-sponsor, Belgium
il y a 1 jour
**_Clinical Research Associate_**
**Your responsibilities will include**:
- Performing site monitoring visits (selection, initiation, monitoring, and close-out) in line with contracted scope of work, regulatory requirements, GCP, and ICH guidelines.
- Providing protocol and study training to sites and maintaining regular communication to manage expectations and address issues.
- Assessing the quality and integrity of site practices, ensuring adherence to protocols and regulations, and escalating issues when necessary.
- Managing study progress by tracking regulatory submissions, recruitment, data entry, and query resolution, with potential support during start-up phases.
- Maintaining site documentation, including filing in the Trial Master File (TMF) and ensuring Investigator's Site File (ISF) compliance.
- Documenting site management activities, monitoring visit findings, and preparing reports and follow-up correspondence.
- Collaborating with the study team to support project execution.
- If applicable, supporting the development of site-specific recruitment plans and managing site finances according to agreements.
**Your profile**:
- University degree in a scientific or healthcare discipline.
- Experience in the pharma industry or clinical trials environment.
- Proficiency in MS Office.
- Fluency in Dutch, French, and English; Belgium-based.
- Strong organizational, time management, and problem-solving skills.
- Ability to build effective working relationships.
- Willingness to travel and hold a valid driver’s license (Class B).
**What you can expect**:
- Resources supporting your career growth.
- Leadership that promotes flexible work schedules.
- Programs to enhance your therapeutic knowledge.
- An excellent working environment within a stable, international, reputable company.
- Company car, mobile phone, and attractive benefits package.
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