Języki
polski
ojczysty
francuski
ojczysty
angielski
dobry
Doświadczenie zawodowe
Clinical Research Associate
Clinical Research Center and Unit of Avicenne hospital, BOBIGNY, 93 (France)
▪ As Clinical Research Associate:
- Initiation and monitoring visits
- Managing queries (generate, follow and resolve)
- Managing SAEs
- Performing all aspects of the monitoring according to the protocol, GCP and ICH
- Reporting and updating studies tracking tools
▪ Additional functions as Clinical Research Coordinator:
- Preparing initial regulatory submissions and amendments
- Registering clinical trials on ANSM website and clinicaltrials.gov
- Budget estimation and billing
- Testing e-CRF
- Preparing different documents : patient's visit and consent form, synopsis, study presentation slideshow, study flyer and newsletters
- Preparing TMF/IMF
▪ Additional functions as Clinical Trial Associate:
- Helping investigators with patient screening
- Collecting patients data
- Inputting data into several e-CRF and queries resolution
- Managing patients SAE and appointments
- Preparing monitoring visits and remote
Phase : III to IV
Therapeutic areas : Ophthalmology, Gastroenterology, Radio-oncology, Intensive Care, Rheumatology and Cardiology
- Initiation and monitoring visits
- Managing queries (generate, follow and resolve)
- Managing SAEs
- Performing all aspects of the monitoring according to the protocol, GCP and ICH
- Reporting and updating studies tracking tools
▪ Additional functions as Clinical Research Coordinator:
- Preparing initial regulatory submissions and amendments
- Registering clinical trials on ANSM website and clinicaltrials.gov
- Budget estimation and billing
- Testing e-CRF
- Preparing different documents : patient's visit and consent form, synopsis, study presentation slideshow, study flyer and newsletters
- Preparing TMF/IMF
▪ Additional functions as Clinical Trial Associate:
- Helping investigators with patient screening
- Collecting patients data
- Inputting data into several e-CRF and queries resolution
- Managing patients SAE and appointments
- Preparing monitoring visits and remote
Phase : III to IV
Therapeutic areas : Ophthalmology, Gastroenterology, Radio-oncology, Intensive Care, Rheumatology and Cardiology
Grupy
BioKariera
O studiach, pracy i karierze w naukach przyrodniczych i biomedycznych (biotech, biopharma, biomedicine & life sciences)