For one of our clients, we are looking for an experience Clinical research associate (CRA), for a phase 3 project in oncology.
CRA experience is a must, previous experience with oncology studies is a plus.
The client, a sponsor, is located in Belgium. As CRA for this project, you will work homebased, and monitor the sites in the Netherlands that take part in the study.
As a Clinical Research Associate (CRA) you are the main communication link between the pharmaceutical company and the investigational staff. You coach the site throughout the clinical study and make sure that it is conducted in accordance with all applicable guidelines.
- You perform monitoring visits from initiation to close out, it will be a combination of risk based monitoring and site visits
- You help with recruitment of patients
- You ensure detailed corresponding reports and administration
- You train your investigational site staff on study specific procedures
- You evaluate appropriate site compliance and data quality
- You respond to site-related queries and escalate site-related issues
- You are responsible for operational site management
- You actively contribute to results oriented department goals
- (Para)medical or scientific degree
- Minimum 1-3 years CRA experience, experience with oncology studies is a plus
- Knowledge and experience in international standards (GCP/ICH), international (FDA,EMA) and local regulations
- Team player, strong interpersonal skills
- Proven expertise in effective communication, in managing multiple priorities and in computer literacy
- Able to work independently within your area of responsibilities
- An eye for detail and affinity with administration, meticulous and quality-minded
- A good knowledge of Dutch and English
- Advanced computer skills
+32 (0)15 21 11 04