пропозиції роботи
Roma Ćwięczek
Clinical Research Associate II
Pszczyna,
śląskie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
Zobacz pełny profil
Umiejętności
ICH-GCP
Linux
Reakcja łańcuchowa polimerazy
VMD
badania kliniczne
znajomość zasad GCP
Clinical Trials Monitoring
ICH GCP
Biotechnologia
biologia molekularna
Biochemia
SYBYL-X
AutoDock Vina
REACH - system rejestracji substancji chemicznych
Języki
angielski
biegły
Doświadczenie zawodowe
In-house Clinical Research Associate
Clinical Consulting Poland
- Set up, adjustment, organization and maintaining of clinical study documentation (e.g. ICF, CRF, etc.)
- TMF documents preparation and verification for COV
- Performing Data Entry role
- Conduct and report all types of onsite monitoring visits
- Involvement in study startup (if applicable)
- Perform source document verification and review, query resolution
- TMF documents preparation and verification for COV
- Performing Data Entry role
- Conduct and report all types of onsite monitoring visits
- Involvement in study startup (if applicable)
- Perform source document verification and review, query resolution
Personal Data Protection Coordinator
Clinical Consulting Poland
Preparation and maintaining of Information Security Policy.
Trainings regarding GDPR requirements.
ICF adjustment regarding GDPR
Trainings regarding GDPR requirements.
ICF adjustment regarding GDPR
Clinical Trial Administrator / Clinical Research Associate
Clinical Consulting Poland
- Preparation and maintenance of tracking systems and tools to support the conduct of a clinical study
- Co-monitoring visits and Source Data Verification
- Participate in feasibility research
- GCP trainings preparation
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Coordination of documents translation
- Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
- Assist with the management of study supplies and organize shipments
- Co-monitoring visits and Source Data Verification
- Participate in feasibility research
- GCP trainings preparation
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Coordination of documents translation
- Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
- Assist with the management of study supplies and organize shipments
Clinical Trial Administrator
Clinical Consulting Poland
- Preparation of Orphan Drug Designation documents for submission to EMA / COMP
- Collection and review of regulatory documents from clinical sites
- Excel / Word / Power Point internal training management
- Collection and review of regulatory documents from clinical sites
- Excel / Word / Power Point internal training management
Intern
Clinical Consulting
Edukacja
Biotechnologia, magisterskie
Uniwersytet Śląski w Katowicach
Chemia sądowa, magisterskie
Uniwersytet Śląski w Katowicach
Chemia leków, licencjackie
Uniwersytet Śląski w Katowicach
Chemia informatyczna, licencjackie
Uniwersytet Śląski w Katowicach
Specjalizacje
Badania i rozwój
Chemia przemysłowa
Badania i rozwój
Farmaceutyka/Biotechnologia
Badania i rozwój
Zarządzanie badaniami i rozwojem
Edukacja/Szkolenia
Coaching
Edukacja/Szkolenia
Rozwój osobisty
Grupy
BioKariera
O studiach, pracy i karierze w naukach przyrodniczych i biomedycznych (biotech, biopharma, biomedicine & life sciences)
Clinical Research & badania medyczne
Grupa dla wszystkich badaczy, lekarzy, naukowców i ludzi biznesu związanych pośrednio i bezpośrednio z medycyną
