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 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 and experienced
Clinical Trial Associate (f/m/d %)
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 SOPs, GCP guidelines, Swiss law, ICH guidelines, and according to local requirements of study sites.
Your Key Responsibilities:
Support the tasks of the Clinical Trial Manager:
* Support all administrative aspects of assigned clinical trials
* Support the management of external service providers and collaborators (CROs, DSMBs, etc.)
* Manage the 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 SOPs, WIs, and related forms.
* Manage and document Change Requests in alignment with GCP standards.
Regulatory Affairs:
* Participate in the compilation of submission dossiers, and others as instructed by the Supervisor
Your Background:
You hold a B.Sc. in a biological or healthcare-related field (e.g., biology, biotechnology, biomedicine, or nursing), or possess a comparable education. Additionally, you bring a minimum of three years of hands-on experience in clinical trials.
Desired Skills and Experience:
* A broad understanding of GCP and regulatory requirements, accredited 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
Grabenstrasse 11, 8952 Schlieren
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 pace start-up environment
* A young and dynamic team
* 26 days of vacations
* One day off for your birthday
Are you curious to find out more?
If you are interested in applying for this position, please send your complete application, which should include the following documents in
English
* One-page motivation letter
* Curriculum vitae
* Copies of degrees and references
by using the following link:
This recruitment is being carried out in collaboration with our HR partner, HC Solutions AG, Annika Danielsson.
For further information regarding the role and the recruitment process, please contact CUTISS AG at
For this position, only direct applications will be considered.