Senior Clinical Research Associate Roosendaal Netherlands,
Posted on : 06 July 2017
- 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
4701 LJ Roosendaal Netherlands
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