- Our company is a small organization with short communication lines and room for initiative.
- The atmosphere is informal. Employees are expected to have a great sense of responsibility and be able to work independently;
- Training, and control is possible.
Senior Clinical Research Associate
- As a senior Clinical Research Associate you independently work on more complex clinical research projects according to our company and/or Sponsor Standard Operating Procedures, ICH-GCP, FDA and other applicable guidelines.
- You are responsible for conduct of feasibility, pre-study and initiation visits, all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, liaise with vendors and for all aspects of site management as prescribed in the project plans.
- In addition to this other duties can be assigned.
Qualifications and experience
- University degree, preferably in science or health related discipline;
- Minimum of 5 years experience in monitoring and conducting global clinical research within GCP/ICH and local guidelines, laws and requirements;
- Extensive knowledge of clinical trial monitoring, Ethics Committee and Competent Authority submissions, site contract negotiations and all applicable regulations and guidelines;
- Excellent written and verbal communication skills;
- Strong organizational, time management, and problem solving skills and the ability to work independently;
- Superior interpersonal skills, able to work within a multicultural environment and assertively deal with difficult situations;
- Proven ability to manage multiple activities, meet timelines and set priorities;
- Fluent in Dutch, English and French, spoken and written;
- Strong knowledge of computers and standard computer applications;
- Flexibility and ability to travel routinely as required by the study