Clinical Research Associate
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Contract type - 12 months (extension likely)
Start Date - August to September
Location - Rotkreuz, near Zug
Workload - 100%
Work type - hybrid possible
Your mission:
* Ensure studies are conducted and documented in accordance with the study protocol, standard operating procedures, good clinical practices and other applicable regulatory requirements.
* Validate product performance claims.
* Supply data for critical Regulatory submissions.
* Define the functional and clinical utility of investigational products.
* Obtain opinions and input regarding investigational products from laboratories or customers, who may be considered key opinion leaders.
* Be responsible for adhering to the policies of the quality system and achieving quality objectives through daily actions.
* Perform or coordinating aspects of clinical studies including site selection, study initiation, site monitoring, and study closeout.
* Maintain communication with study investigators to ensure studies are completed in a timely fashion and ensuring that study objectives are met.
* Interface with cross functional staff to support post launch activities
* Review cases with investigators to resolve discrepancies.
* Ensure that studies adhere to FDA regulations, Good Clinical Practices, IVD directives, and company policies and procedures.
Your background:
* Min. 2 years of prior relevant experience (MANDATORY)
* Bachelor's degree in science or relevant field, Medical technology degree preferred, but not required if R&D background is adequate (MANDATORY)
* 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) (MANDATORY)
* Experience in clinical research or laboratory research (preferred)
* Medical laboratory experience (preferred)
* Experience in pathology (preferred)
* 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
* 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
What's on offer
* An initially 12 month contract, with likely extension, at an internationally-renowned pharmaceutical company.
* A competitive salary.
* A flexible hybrid working policy.
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
Website
https://www.swisslinx.com/job/16094en