Ogłoszenie numer: 504537, from 2014-09-03
DOKUMEDS SIA, Sp. z o.o. Przedstawicielstwo w Polsce
CRA is responsible for study site management including site selection, initiation, routine monitoring, close-out and maintenance of study files. CRA also ensure the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
Clinical Research Associate (CRA)
Location: Warszawa
Job description
- Site administration and site monitoring responsibility for clinical studies according to DOKUMEDS and Sponsor Standard Operating Procedures, legal requirements and ICH-GCP Guidelines
- Conduction of country and site feasibility
- Performance of initiation, routine monitoring and close-out visits
- Preparation and performance of submissions to Ethics Committee/ Regulatory Authorities
- Assistance in project budget and contract management
- Completing Serious Adverse Event (SAE) reporting, processing, production of reports
Requirements
- University degree in medicine, pharmacy, nursing or biology
- Previous experience in independent monitoring
- Excellent knowledge of English, Polish languages
- Thorough knowledge of ICH-GCP guidelines including an understanding of local regulatory requirements
- Availability to travel
- Strong organizational, communication and teamwork skills
- Computer literacy
- Driving licence
We offer
- Flexibility in contractual conditions: freelancer, part time contractor, permanent team member
- Possibility to plan your own working time according to contract obligations
- Opportunity to work for international and quickly growing company
- Competitive salary, professional development
Please add the following clause: I agree to the processing of my personal data for the needs necessary in the recruitment process.