Clinical Research Associate (m/f)

REFERENZNUMMER:

355657/11

IHRE AUFGABEN:

-Execution of external evaluations
-Support Study Manager to plan, coordinate and conduct external validation activities for new systems, software versions, and reagents
-Organize all required activities and tasks in cooperation with other Clinical Operations departments
-Support training activities of the evaluation sites, study monitoring, statistical calculations and interpretations, troubleshooting and study close out
-Ensure the usability of validated programs and compliance of legal and regulatory requirements at the involved evaluation sites
-Be responsible for preparation of study relevant documentation
-Closely cooperate with internal and external partners to ensure optimal course of evaluation projects

IHRE QUALIFIKATIONEN:

-Scientific or technical degree, preferably training as a biology/chemistry lab technician
-Experience as CRA
-Knowledge about lab automation, workflow and understanding of in vitro diagnostics laboratories
-Knowledge of applicable standards and regulations for clinical trial and lab conduct as well as experience in study monitoring
-Preferable knowledge in the field of Coagulation
-Fluency in English and driving license Cat. B
-Travelling up to 20%

WEITERE QUALIFIKATIONEN:

CRA