Umiejętności
Clinical Research Experience
ICH-GCP
Quality Assurance Processes
Clinical Trials Management
Conducting Clinical Trials
Języki
angielski
dobry
niemiecki
podstawowy
Doświadczenie zawodowe
Clinical Study Coordinator
• participating in studies’ Phases II-IV
• organizing of MV (Site Evaluation Visit, Site Initiation Visit, Regular Monitoring Visit, Close-Out Visits, Monitoring Remote Visits)
• representing site on Investigators’ Meetings
• preparing templates for Patients’ visit according to study protocol, quality control of source documentation
• ISF maintenance and study material (site correspondence management, keeping certificates of site equipment’s up to date)
• management and organizing laboratory work, training study nurses, shipping out biological samples according to IATA instructions
• inventory lab kits and ordering re-supply
• eCRF completion and queries resolution: RAVE, InForm, Clincase, Viedoc, Bioclinica
• IP/NON-IP management – completing IP logs, temperatures logs, IP handling, dispensation and collection, ordering IP
• patient training (e-diary, compliance, questionnaires )
• IVRS calls: Cenduit, Clincase, S-Clinica, ClinPhone, Almac, Endpoint
• contacting with Sponsors’ representative
• responsible for site finance, review contracts and budget
• organizing of MV (Site Evaluation Visit, Site Initiation Visit, Regular Monitoring Visit, Close-Out Visits, Monitoring Remote Visits)
• representing site on Investigators’ Meetings
• preparing templates for Patients’ visit according to study protocol, quality control of source documentation
• ISF maintenance and study material (site correspondence management, keeping certificates of site equipment’s up to date)
• management and organizing laboratory work, training study nurses, shipping out biological samples according to IATA instructions
• inventory lab kits and ordering re-supply
• eCRF completion and queries resolution: RAVE, InForm, Clincase, Viedoc, Bioclinica
• IP/NON-IP management – completing IP logs, temperatures logs, IP handling, dispensation and collection, ordering IP
• patient training (e-diary, compliance, questionnaires )
• IVRS calls: Cenduit, Clincase, S-Clinica, ClinPhone, Almac, Endpoint
• contacting with Sponsors’ representative
• responsible for site finance, review contracts and budget
Szkolenia i kursy
Apr 2014 - „Investigator Site personel ICH GCP Training Certificate” conducted by TransCelerate Biopharma Inc.
24-oct-2014 - Prague. Investigator meeting- Sponsor: Gilead. Study: GS-US-312-0123
24-oct-2014 - Prague. Investigator meeting- Sponsor: Gilead. Study: GS-US-312-0123
Edukacja
Specjalizacje
Badania i rozwój
Farmaceutyka/Biotechnologia
Badania i rozwój
Inne
Badania i rozwój
Zarządzanie badaniami i rozwojem
Zainteresowania
Handball - member of Polish National Team (2006 – 2007), currently amateur
Inne
Skills and qualification:
- Good communication abilities, excellent interpersonal skills, ability to work well under stress, conscientiousness
- Self-motivated, organized, adaptable, passionate and ready to meet new challenges
- Superior computer skills - MS Windows and MS Office (Word, Excel, PowerPoint – all versions)
- Clean driving license
- Good communication abilities, excellent interpersonal skills, ability to work well under stress, conscientiousness
- Self-motivated, organized, adaptable, passionate and ready to meet new challenges
- Superior computer skills - MS Windows and MS Office (Word, Excel, PowerPoint – all versions)
- Clean driving license
Grupy
A jak zarobić pierwszy milion.
Jeśli jesteś osobą, która chce zarabiać w milionach, lub już tak zarabia to jest to grupa dla ciebie :)
Clinical Research & badania medyczne
Grupa dla wszystkich badaczy, lekarzy, naukowców i ludzi biznesu związanych pośrednio i bezpośrednio z medycyną
Praca w branży medycznej i farmaceutycznej
medycyna, farmacja - oferty pracy, opinie o pracodawcach, informacje o branży