Clinical Research Associate

Position: Clinical Research Associate (M/F)

Location: Zürich Switzerland

Start: January 2019

 

 

Company activity:

Luciole Medical is a medical device company located in Zürich Switzerland. The company has a proprietary technology in NIRS and has developed a platform of devices to measure cerebral oxygenation and other parameters. The company obtained CE mark for ist invasive brain monitoring system. 

Job description:

The candidate will develop and implement a clinical plan to generate data on both elements of the system (probe and patch), to support regulatory process and commercial activity in EU and USA.

The function includes:

-       Identification and selection of KOL or primary investigators

-       Development of study protocols

-       Obtaining relevant approvals (Swiss medic, ethic committees)

-       Organizing and conducting Clinical Advisory Board meeting

-       Managing publication and clinical/scientific communication process

-       Supervising and monitoring data management in various centers

-       Supervising clinical logistic and supply

-       Support interaction with regulatory authority and notified bodies

-       Interface with engineeering and development team to ensure feedbacks being reflected in system

 

Organization 

Report to CEO

 

Qualification

-       Master degree in biology, medical engineering, MD, pharmacist

-       Specific qualification in RA or clinical studies management

-       Fluent English, German or French would be a plus

 

Experience

Experience of minimum 3 years in similar function is required.

 

Profile

Candidate is rigorous, honest and autonomous. He/She is able to interact with clinical investigators and regulatory bodies. Passionate about technology and healthcare with very high ethical and performance standards.

Candidate is comfortable in multicultural international environment and able to perform in a small company.