PARIS
Summary
• Implementation and monitoring of clinical studies; ensures sponsor and investigator obligations are being met and are in compliance with local regulatory requirements.
• Perform feasibility and site qualification visits in order to select qualified sites
• Perform monoitoring and other types of visits
• Maintain iTMF and keep it up to date
• Perfom drug accountability at investigative sites
• Support the investigators and sponsor in study logistics
• Ensure SAE reporting according to project specification
• Serve as key contact for the investigator
• Collect and reviews regulatory documents
• Support sponsor in fulfilling their obligations with regard to submissions according to relevant regulatory requirements
Specialties:- Languages: Russian - native language; Fluent in English and French
- Fully trained to work in scientific laboratories that comply with GLP and GMP regulations
- Capable of giving training to other members of team
- Assays responsible for : bio-potency assay, tissue culture, virus-based assays, in vitro and plaque neutralisation assays etc.
- IT : Confident in working with Microsoft Word, Excel, Power Point, Outlook and Internet resources
Mes compétences :
Biologie
Biology
Biotechnologie
Biotechnology
BPF
BPL
GMP
Médical
Pharmacie
Qualité
Quality
Recherche
Recherche clinique
Research
Virologie
