Do you have a scientific background and have you had a first taste of working 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.
Job Description
As a Clinical Research Associate (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.
Responsibilities
- You evaluate, initiate, monitor & close out clinical trial sites.
- You ensure site compliance and data quality
- You respond to site-related queries and escalates issues
- You responsible for operational site management
- You actively contribute to department results and goals
Key Activities:
- You develop site visit plans, conduct Clinical Site Evaluation, Initiation, Monitoring and Close Out visits and prepare visit reports for project manager review and approval.
- You build and maintain solid and long-term professional relationships with investigators and site staff
- You facilitate subject enrollment at the site level with focused patient recruitment strategies and action plans
- You assist in preparing sites for audits, review audit reports and contribute to resolving findings
- You 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
- You ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAES)
- You verify case reports and source documentation
- You provide input into case report forms and study-related documents as requested
- You perform investigational product accountability and reconciliation.
- You maintain site study supplies
- You facilitate the resolution of clinical queries to investigative staff
- You provide input into feasibility and identify clinical investigators
- You ensure clinical study sites are conducting the clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
Requirements
- 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
- Flexibility
- Good communication skills
- Presentation skills
- Problem solver
- Team player
- Existing right to work in Europe required
Benefits
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 18742
