Skills :
- Manage feasability.
- Manage study start-up (ethic submission, study document review, financial contract, overcost negotiation).
- Coordinate studies.
- Perform selection, initiation, monitoring and close-out visits.
- Manage site activities.
- Provide medical team training.
- Experience in several pathology areas from Phase I to Post marketing.
- Act as a mentor including accompanied and assessment CRA visits and operational CRA team support.
Mes compétences :
Monitoring
Clinical research
EDC
Site selection
Ethic submission
Feasability
Site management
Oncology
ICH-GCP
Contract management
Start-up
Quality management
E-CRF
Local study management
Overcosts negotiation
Study closeout
Clinical Trials
CTMS
Several therapeutic areas
Full monitoring activities
Onco-Hematology