Clinical and Regulatory Research Specialist

About the job

Recherche

Clinical and regulatory research specialist

The NeuroRestore laboratory at CHUV (Lausanne University Hospital) is offering a position for a Clinical and Regulatory Research Specialist for an occupational rate of 80% - 100%.

Contexte

The Lausanne University Hospital CHUV is one in five university hospitals in Switzerland, and the only one in the French-speaking part of the country carrying out DBS implantations for Parkinsonian conditions, with more than 50 cases per year. Academically, it is linked to the Faculty of Biology and Medicine of the University of Lausanne (UNIL) and it holds close ties to the Swiss Federal Institute of Technology in Lausanne (EPFL).

NeuroRestore is a research and innovation center spanning EPFL and CHUV that develops bioengineering strategies involving neurosurgical interventions to restore neurological functions. Our innovative treatments result from rigorous preclinical studies that have been conducted during the last 15 years in rodent and non-human primate models.

At CHUV, we perform early feasibility clinical trials (C2) with implantable neurotechnologies (Class III medical device) to restore neurological functions in people with Spinal Cord Injury, Parkinson’s Disease, or Stroke.

Mission

CHUV is seeking for a Clinical and Regulatory Research Specialist to lead the preparation of regulatory submissions and support the clinical team in the management of clinical trials. The specialist will contribute to several studies in parallel and be involved in all phases of a clinical trial, from study start-up through to study completion.

Prepare clinical documentation for submission to the ethics committee and the competent authority:

• Write clinical trial amendments and documentation for submission to Swissmedic and CER-VD.
• Support writing and review of medical device technical files, such as risk management activities, requirements, testing plan and reports.

Support the conduct of ongoing clinical trials:

• Ensure trials are conducted according to the protocol.
• Manage case report forms completeness.
• Perform Trial Master Files & Investigator Site Files completeness checks.
• Perform data completeness checks prior monitoring visit.

Profil

• Master degree in biomedical engineering or similar.
• Minimum 2 years of experience in clinical operations/ regulatory field.
• Excellent rigor and attention to detail.
• Solid understanding of clinical trial processes, GCP, and regulatory requirements.
• Fluency in English.
• Ability to work independently along with a multidisciplinary team on a large portfolio of clinical trials.

Nice to have:

• Prior experience in medical devices clinical trials strongly preferred.
• Experience with medical device risk management processes (ISO 14971)
• Interest in neuromodulation therapies.

Nous offrons

To become an employee of the world-famous University Hospital Center from the Canton of Vaud is an assurance of:

• First-rate social benefits such as a Paternity Leave of 20 days and a Maternity Leave of 4 months (there is also the possibility to obtain a complementary breastfeeding leave of 1 month)
• Regular salary progression adapted to your responsibilities
• A 13th salary and 25 days of vacations per year
• A right to at least three days of training per year, by accessing a wide offer of courses not only from the CHUV Training Center but also from external providers
• Possibility to access one of the 500 furnished apartments offered in the surrounding neighborhoods in case of relocation in Switzerland
• Discounts proposed on social and cultural events, goodies and other services, thanks to the “H-Oxygène” association
• Signing up to our Mobility Plan and benefit from different advantages (discounts on public transportation, promotion of “Mobility” car fleet and discounts on electric bikes)
• Being able to enjoy our high-quality corporate restaurants, located in every hospital building, with employees’ discount

Contact et envoi de candidature

Contact pour informations sur la fonction : Léa Bole-Feysot, chercheuse, E-Mail schreiben.

All of our applications are processed electronically. For this reason, we kindly ask you to apply exclusively by clicking on the APPLY button at the bottom of the advertisement.

Should you experience any problems with your application, you can consult our document "how to apply online". In case of technical issues, you can contact our Recruitment team who will help you (E-Mail schreiben / +41 21 314 85 70)

The CHUV applies the highest quality requirements as part of its recruitment process. In addition, mindful to promote workplace diversity and inclusion we strive to ensure equal treatment and avoid any discrimination. We are looking forward to receiving your application.

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