Descripción
* Zug
* Contracting
* Vollzeit
* As soon as possible - 1 year/will be extended
Start date: ASAP
Duration: 1 year
**Responsibilities:**
* Ensuring studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements
* Validating product performance claims
* Supplying data for critical Regulatory submissions
* Defining the functional and clinical utility of investigational products
* Obtaining opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders
* The CRA is responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions
* Performing or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout
* Maintaining communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met
* Interfacing with cross functional staff to support post launch activities
* Reviewing cases with investigators to resolve discrepancies
* Ensuring that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, policies and procedures
**Requirements:**
* Bachelor-s degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate
* -Preferably experience in clinical research or laboratory research
* Min. 2 years of prior relevant experience
* Basic knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines) - Excellent oral and written communication skills in English
* Good therapeutic and protocol knowledge.