Clinical Research Associate
As a CRA you are part of the clinical project team and you are responsible for overseeing the conduct of specific clinical research projects in the investigational sites.
In this role you assure that the clinical project is conducted according to the company’s SOPs and applicable guidelines and regulations.
You act as the main line of communication between the sponsor and the investigational sites.
A few of the different responsibilities that you will have, are:
- Ensure clinical trials are conducted in compliance with study protocol, sponsor SOPs and applicable guidelines and regulations
- Participate in trial set-up activities and site selection process as required
- Assist with preparation of ethics committee and regulatory submissions
- Perform feasibilities (as required)
- Ensure proper training of the site’s study team on the clinical project and adherence to applicable guidelines and regulations
- Conduct on-site visits from site initiation to site close-out
- Write visit reports
- Ensure collection of all required essential documents throughout the study
- Manage distribution and return of clinical trial supplies (incl. investigational product)
- Identify and resolve routine study conduct issues and document preventive/corrective actions
- Act as the key liaison between clinical investigators, study site personnel & the sponsor
- ...
- University degree or Bachelor in medical/paramedical sciences, or equivalent through experience
- Monitoring experience
- Knowledge of GCP guidelines & EU Directives
- Language skills (English, Dutch, French...)
- Belgian residence required, since this vacancy is office based
Work habits and personality include:
- Ability to function well independently as within a study team
- Well organized, accurate, detailed
- Flexible, transparent team player
- Quality oriented with commercial awareness
- Conduct in a mature professional way that underwrites the Fern Valley values
As an employee of Fern Valley you will receive
- an attractive salary in line with your experience and skills
- fringe benefits (including a company car, meal allowance, medical insurance, pension plan, a care plan...)
- a supporting environment throughout your mission with our customer & career planning
- respect for life-work balance
- our commitment towards your professional and personal growth through tailor-made trainings and coaching
Evelien Van Eecke
Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.