Clinical Research Associate, 100% - Zug, Schweiz - Implantica

Implantica
Implantica
Geprüftes Unternehmen
Zug, Schweiz

vor 1 Woche

Lena Schneider

Geschrieben von:

Lena Schneider

beBee Recruiter
Beschreibung
**About Implantica Group
Implantica is a medtech group dedicated to bringing advanced technology into the body.
Implantica's lead product, RefluxStop, is a CE-marked implant for the prevention of
gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as
supported by successful clinical trial results. Implantica also focuses on eHealth inside the body and
has developed a broad, patent protected, product pipeline based partly on two platform

technologies:
an eHealth platform designed to monitor a broad range of health parameters, control
treatment from inside the body and communicate to the caregiver on distance and a wireless
energizing platform designed to power remote-controlled implants wirelessly through intact skin.


_We are seeking immediately a Clinical Research Associate, 100% (M/F/n), for a 1 month long _

_fixed term contract (possibility to extend to 2 months)._

Key Responsibilities:


  • Conduct clinical site audits to assess compliance with the study protocol, GCP
guidelines, and applicable regulatory requirements.

  • Correct the previously identified findings
  • Prepare the sites for the BIMO inspection
  • Ensure completeness of Sponsor files
  • Auditing and document review of:
  • Clinical protocols, and reports trial protocol, informed consent forms, and
case report forms.

  • Submissions for ethics approval
  • Trial Master Files (TMFs)
  • Contract Research Organization
  • Verification of data accuracy by comparing source documents (e.g.,
medical records) with the data reported to the sponsor

  • Assessment of SAE/AE reporting and handling
  • Evaluation of the storage and handling of investigational products

Your profile:


  • Fluency in Hungarian and English
  • At least 5 years of monitoring and medical device clinical trial experience
  • Experience with BIMO inspections is a plus
  • Immediate availability

We offer you:


  • A challenging and exciting position in an open and dynamic company
  • A motivated, dedicated and international team
  • Modern working conditions and competitive remuneration
**Interested?
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