Clinical Research Associate Leuven (m/f) in HAASRODE
For one of our clients we are looking for: Clinical Research Associate Leuven (m/f) - HAASRODE (m/f):
Job description:
Taking the complexity of the headquarters of a division of an important corporation, a global leader in the health care business, the job duties can be categorized into different fields:
1. Preparation and Coordination of Clinical Trials
• Assistance in preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patients information,...)
• Assistance in preparation of files for the submission to Ethical committee, Competent Authority and other bodies if needed
• Preparation of files for Clinical trial insurance
• Follow-up of agreements with hospitals and investigators
• Technical preparation of Investigators and Steering Meetings
• Check the status of patients enrolment in hospitals and feed back the status to investigators periodically
• Clinical trials monitoring
• Provide assistance to global Clinical and Regulatory personnel
2. General administration related to the clinical trials
• Management of all documentation about clinical trials
• Management of invoices related to clinical trials
3. Regulatory issues
• Closely follow the regulations related to conduct of clinical trials in different countries
• SOP preparation and update
4. Clinical data analysis
• Data input for trials and registries
• Formulate queries and inquiries in case of missing or unidentified data in case cards
• Data analysis
• Preparation of presentation
5. General
• Act as a representative of the company.
• Assume all other responsibilities and authorities this function may require regarding new opportunities.
• General monthly reporting to European Medical and Clinical Division Manager
Requirements:
• Medical or paramedical background
• Experience in Clinical trials
• Well developed computer skills, communication skills, and presentation skills
• Good administration skills
• Must be able to work in an international environment
• Fluent in English and one other European language
• Ability to function in a self-directed manner with a high degree of independence
We offer:
An open ended contract
Contact:
Sandra Rizzuto