Do you have a scientific background and have you had a first taste or want to work in the pharmaceutical/medical device industry ? Are you triggered to find out more about the development of new treatments for patients and orient your career in this direction ? Then check out the below, we are actively looking for enthusiastic Clinical Research Associate (CRA) candidates, motivated and eager to dive in and further explore the world of clinical research."
- As a CRA you plan, execute, and support clinical site management activities
- You ensure the quality and integrity of the data collected in the client sponsored clinical trials
- Evaluate, initiate, monitor & close out clinical trial sites.
- Ensure site compliance and data quality
- Respond to site-related queries and escalates issues
- Responsible for operational site management
- Actively contribute to department results and goals
- Develop site visit plans, conduct Clinical Site Evaluation, Initiation, Monitoring and Close Out visits and prepare visit reports for project manager review and approval.
- Build and maintain solid and long-term professional relationships with investigators and site staff
- Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
- Assist in preparing sites for audits, review audit reports and contribute to resolving findings
- Identify site needs and site-related issues, escalate and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
- Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAES)
- Verify case reports and source documentation
- Provide input into case report forms and study-related documents as requested
- Perform investigational product accountability and reconciliation.
- Maintain site study supplies
- Facilitate the resolution of clinical queries to investigative staff
- Provide input into feasibility and identify clinical investigators
- Ensure clinical study sites are conducting the clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
- Bachelor or Master in sciences
- First relevant experience (internship or industry)
- Very good knowledge of Dutch, French and English
- Good working knowledge of common software packages
- Attention to detail
- Good organizational skills
- Relationship building skills
- Good communication skills
- Presentation skills
- Existing right to work in Europe
- Indefinite contract with a balanced salary package based on your capabilities and experience, including extra legal benefits.
Vacancy number: 18829