Description
For a global clinical research organization I am looking for a freelancer as SSU & Regulatory Specialist. You should be available for min. 0.7 FTE (best 5 days) per week for the next 6 month as soon as possible (July 2014).Your tasks are:
- Reviewing essential document packages for site activation
- Preparation and submitting of Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required in Denmark
- Reviewing Informed Consent Forms
Client requirements are:
- Excellent knowledge of local regulatory requirements/guidelines (such as Code of Federal Regulations) & European Union Directive in Denmark in the last year(s)
- profound experience with submissions (please note how many)
- previous experience in clinical research including submissions experience
- Fluent in English (written and speaking), Danish would be a plus
Location: Denmark - in home office
Start date: as soon as possible or latest 01. July 2014
Hourly Rate: Negotiable
Hours per week: 0.7 FTE (better full time)
Project length: 4-6 month
Interested?
We could give you more information about this position, your contact person is Sheila Brauns.
Contact details:
Sheila Brauns
Please upload your CV as a word document.