Clinical Research Associate, Medical Technology & Diagnostics (80-100%) (6714 – KFR)
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Clinical Research Associate, Medical Technology & Diagnostics (80-100%)
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.
We are currently looking for a Clinical Research Associate, Medical Technology & Diagnostics for an unlimited contract (12 months initially with planned extension) based in Zug area, Switzerland.
Max. 40% home office possible. 25-30% travelling within Europe.
The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
Main 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
Being 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, and client’s policies and procedures
Qualifications and Experience:
Relevant working/residency permit or Swiss/EU-Citizenship required
Bachelor’s degree (Masters and PhD also ok) 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
Excellent planning, organizing, and interpersonal skills
Ability to work independently, make sound decisions, and to analyze and solve problems
Medical laboratory experience preferred
Good therapeutic and protocol knowledge.
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
Organizational and problem-solving skills
Effective time and financial management skills
Ability to establish and maintain effective working relationships with coworkers, managers, and clients
Nice to Have:
Experience in pathology
Seniority level
Associate
Employment type
Temporary
Job function
Research and Science
Medical Equipment Manufacturing
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