Clinical Research Associate
Consultancy
Information
Do you want to make an impact as Clinical Research Professional? Do you want to protect the safety & well-being of subjects and guarantee data quality? Do you get energy from daily communication with investigators, study coordinators and study teams? Do GCP ICH E6 R2 and ISO 14155 have no secrets anymore for you? Do you like to perform monitoring visits in hospitals?
Your responsibilities:
* Initiates, monitors and closes study sites in compliance with procedural documents
* Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements
* Proactively identifies study-related issues and finds the appropriate solutions independently or in cooperation with the study team lead
* Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ISO/GCP requirements in order to ensure data integrity and subject safety
* Carries out source data verification (SDV) according to the monitoring or SDV plan.
* Ensures data query resolution
What's in it for you?
The QbD group is a healthy international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you:
* The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics
* A company with a clear strategy and ambition
* Develop your skills in a world class team of specialists
* Value driven and data driven company
* Award winning company
More info?
https://qbdgroup.com/en/vacancies/clinical-research-associate/