Senior CRA
PSI
Leuven, Belgium
5 dagen geleden

As a Senior CRA you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.

You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-

being and quality of data compliance.

You will :

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Supervise study activities, timelines, and schedules on the country level
  • Be a point of contact for in-house support services and vendors
  • Be involved in quality control, such as compliance monitoring and reports review
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions
  • Qualifications

  • College / University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience in Belgium
  • Experience in all types of monitoring visits in Phase II and / or III
  • 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, collaboration, and problem-solving skills
  • Ability to travel
  • Valid driver’s license
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