Sr. Clinical Study Assistant The Netherlands - Netherlands,
What is the vacancy about
Verify all internal documents on completeness and correctness:
1. Readability of data, date and signature
2. Use of correct document version
3. Translation present with certificate if necessary
4. Approval received for all necessary documents (from company stand point as well as from authority standpoint)
Updating filing database (TMF or Trial Master File; i.e. the in-house mother file of study related docs) with newly received documents / correspondence
Collect all the documents needed to start sites (collection of the so called Essential Docs to
1. Submit sites to the competent authorities; i.e. MoH and EC
2. Allow initiation of the site
Assist CRA regarding filing/documentation
Follow-up of documents that need to be returned from sites (e.g. CV, GCP certificates, calibration reports,…)
Make Note-to-Files to explain occurred errors
Check patient payment reports for performed hospital visits
Keep trackers of
1. Active persons on site (add stop date if necessary)
2. Payment letters
Experiences as Clinical Trial Assistant and/or Clinical Support Specialist.
MZD is specialized in providing freelance Clinical Research Professionals to the Pharmaceutical and Medical Device Industrie. The freelancer is going to work under our contract for our client. Our client is an international Medical Device Company.
The salary is based on a hourly rate basis.
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