CUTISS AG, a biotech company spin-off of the University of Zurich (UZH), focuses on the development of personalized bioengineered skin graft products for the treatment of skin defects. Its lead product denovoSkin™ has successfully completed Phase I and II in burns patients. Clinical Phase III studies are underway in Europe and Switzerland.
For our headquarters in Schlieren, Switzerland, we are currently seeking a motivated
Clinical Trial Associate (f/m/d) (100%) The Clinical Trial Associate will support the clinical department of CUTISS in implementing, managing, and maintaining the activities and processes related to the clinical trials with autologous skin substitutes. Activities are performed according to internal Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, Swiss law, International Council for Harmonisation (ICH) guidelines, and according to local requirements of study sites.
Your Key Responsibilities:
Support all administrative aspects of assigned clinical trials
Support the management of external service providers and collaborators such as Contract Research Organizations (CROs) and Data Safety Monitoring Boards (DSMBs)
Manage the Investigational Medicinal Product (IMP) supply by communication with sites, service providers and manufacturing team
Support with and conduct training of investigators, site and service provider staff as applicable
Create study specific training material and monitoring tools
Assist in the creation and review of study specific documentation such as the protocol and relevant amendments, case report forms, patient information sheets, etc.
Prepare and update project-specific documentation such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and related forms.
Manage and document Change Requests in alignment with Good Clinical Practice (GCP) standards.
Participate in the compilation of submission dossiers, and others as instructed by the Supervisor
Your Background: You hold a Bachelor of Science (B.Sc.) in a biological or healthcare-related field (e.g., biology, biotechnology, biomedicine, or nursing) or possess a comparable education. Working experience is a plus.
Desired Skills and Experience:
A broad understanding of Good Clinical Practice (GCP) and regulatory requirements, accredited Good Clinical Practice (GCP) course is a plus
Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.
Able to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
Precise and accurate work
Excellent oral and written communication and presentation skills
Fluent in English (written and spoken); other languages are a plus
Place of work: We offer the unique chance to be part of a young and motivated project team with the vision to change the patients’ quality of life. This interesting role will give you the opportunity to further develop your working skills in a biotech start-up environment and to get in touch with international partners and clinical trial centers. In summary you can expect:
Fast-paced start-up environment
A young and dynamic team
26 days of vacation
One day off for your birthday
#J-18808-Ljbffr
For our headquarters in Schlieren, Switzerland, we are currently seeking a motivated
Clinical Trial Associate (f/m/d) (100%) The Clinical Trial Associate will support the clinical department of CUTISS in implementing, managing, and maintaining the activities and processes related to the clinical trials with autologous skin substitutes. Activities are performed according to internal Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, Swiss law, International Council for Harmonisation (ICH) guidelines, and according to local requirements of study sites.
Your Key Responsibilities:
Support all administrative aspects of assigned clinical trials
Support the management of external service providers and collaborators such as Contract Research Organizations (CROs) and Data Safety Monitoring Boards (DSMBs)
Manage the Investigational Medicinal Product (IMP) supply by communication with sites, service providers and manufacturing team
Support with and conduct training of investigators, site and service provider staff as applicable
Create study specific training material and monitoring tools
Assist in the creation and review of study specific documentation such as the protocol and relevant amendments, case report forms, patient information sheets, etc.
Prepare and update project-specific documentation such as Standard Operating Procedures (SOPs), Work Instructions (WIs), and related forms.
Manage and document Change Requests in alignment with Good Clinical Practice (GCP) standards.
Participate in the compilation of submission dossiers, and others as instructed by the Supervisor
Your Background: You hold a Bachelor of Science (B.Sc.) in a biological or healthcare-related field (e.g., biology, biotechnology, biomedicine, or nursing) or possess a comparable education. Working experience is a plus.
Desired Skills and Experience:
A broad understanding of Good Clinical Practice (GCP) and regulatory requirements, accredited Good Clinical Practice (GCP) course is a plus
Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.
Able to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.
Precise and accurate work
Excellent oral and written communication and presentation skills
Fluent in English (written and spoken); other languages are a plus
Place of work: We offer the unique chance to be part of a young and motivated project team with the vision to change the patients’ quality of life. This interesting role will give you the opportunity to further develop your working skills in a biotech start-up environment and to get in touch with international partners and clinical trial centers. In summary you can expect:
Fast-paced start-up environment
A young and dynamic team
26 days of vacation
One day off for your birthday
#J-18808-Ljbffr
Clinical Trial Associate 100% (f/m/d) Arbeitgeber: CUTISS AG
CUTISS AG ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einem dynamischen und innovativen Umfeld zu arbeiten, das sich auf die Entwicklung personalisierter bioengineered Hauttransplantate konzentriert. Mit einem engagierten Team in Schlieren, Schweiz, profitieren Sie von einer offenen Unternehmenskultur, umfangreichen Weiterbildungsmöglichkeiten und attraktiven Benefits wie 26 Urlaubstagen und einem zusätzlichen freien Tag zum Geburtstag. Hier haben Sie die Chance, Ihre Fähigkeiten in der Qualitätssicherung weiterzuentwickeln und aktiv zur Verbesserung der Lebensqualität von Patienten beizutragen.
