As a Senior CRA II you will work on the frontline of communication with project stakeholders, ensuring the successful conduct of clinical trials in a variety of therapeutic indications. You will perform and supervise study start-up, clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and compliance with the protocol, ICH GCP, regulatory and PSI/ Sponsor specific requirements on a country/regional level.
- Supervise study activities, timelines, and schedules on a country/regional level
- Coordinate start-up processes
- Review monitoring visit reports for all visit types and supervise and support Monitors in their activities
- Act as the main communication line between Monitor and Regional Lead or Project Manager
- Be a point of contact for in-house support services and vendors
- Lead project team calls on a country level
- Ensure ongoing evaluation of quality at a country/regional level, through report reviews, co-monitoring, onsite and in-house training, etc.
- Conduct site audit preparation visits, resolve or support resolution of site audit findings
- May need to monitor and manage sites (if applicable)
- Preparation and delivering of presentations at Investigator’s Meetings
- Maintain study-specific and corporate tracking systems at site and country level
- College/University degree in Life Sciences or an equivalent combination of education, training & experience
- Minimum of 4 years independent on-site monitoring experience
- Participation in clinical projects as a Lead/Senior Monitor
- Full working proficiency in English, Dutch and French
- Proficiency in MS Office applications
- Ability to plan, multitask and work in a dynamic team environment
- Communication, leadership, and problem-solving skills
- Valid driver’s license
Take your first step towards a career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.