Senior CRA II/ Lead Monitor
PSI CRO
Leuven, Flanders, Belgium
3 dagen geleden
Job Description

Office-based

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

Qualifications

  • 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


Additional Information

Take your first step towards a career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

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