Clinical Research Associate

Swisslinx

Swisslinx

Infos sur l'emploi

  • Date de publication :

    26 juin 2024
  • Taux d'activité :

    100%
  • Type de contrat :

    Temporaire
  • Langue :

    anglais (Courant)
  • Lieu de travail :

    Rotkreuz
On behalf of our client, a leading international pharmaceutical company, Swisslinx is looking for a Clinical Research Associate. If this is you, you will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.

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)

Contact

  • Swisslinx