Clinical Quality Specialist 60-70%
For our Clinical Trial Unit, we are looking for a
Clinical Quality Specialist 60-70%
- Plan and perform monitoring visits for prospective clinical studies according to monitoring plans
- Develop monitoring plans (including risk analysis) in collaboration with the respective study teams
- Further develop and implement the risk-based monitoring approach in the institution
- Promote the implementation of the ICH Good Clinical Practice (ICH-GCP) guidelines
- Be subject matter expert for regulatory affairs related topics in the context of clinical trials and research projects
- Be responsible for study specific quality management systems based on a risk based approach; i.e. provision of respective templates for study related processes
- Support study teams in the context of audits and inspections by ethics committees or regulatory authorities
- Teach on national and international clinical research regulations (e.g. Human Research Act (HFG); ICH-GCP guidelines)
- Be responsible for the maintenance of the archive for all studies under the Human Research Act
- Master in health or natural sciences
- Excellent knowledge and experience of processes in patient-oriented research; including trials with medical devices and medicinal products (e.g. experience as study coordinator)
- Profound knowledge of and experience in working with national and international clinical research regulations (e.g. HFG, ICH-GCP)
- Experience with audits and inspections by ethics committees or regulatory authorities is an advantage
- Good knowledge of rehabilitation medicine and spinal cord injury/disease is an advantage
- Excellent German (business fluent) and good English language skills; both spoken and written
- Soft skills: Self-managed way of working, strong customer orientation, able to work in a team, excellent communication skills
- Excellent conditions for innovative, vital- and implementation-oriented research in the context of SCI epidemiology
- A position in a stimulating and productive working atmosphere
The position is available for a period of 3 years with the possibility of an extension (starting upon agreement).
For further information please contact Christine Thyrian, Head CTU SPF, T 041 939 65 94.
Interested? We are looking forward to your online application in English (including your curriculum vitae, diplomas and a cover letter with a personal statement regarding your suitability and motivation) on, www.paraplegie.ch/jobs. Evaluation of applications will take place on an ongoing basis.
6207 Nottwil
Lieu de travail
Guido A. Zäch Str. 10
6207 Nottwil