Clinical Quality Specialist 60-70%
Schweizer Paraplegiker-Forschung AG
Infos sur l'emploi
- Date de publication :11 octobre 2024
- Taux d'activité :60 – 70%
- Type de contrat :Durée indéterminée
- Langue :allemand (Courant), anglais (Intermédiaire)
- Lieu de travail :Nottwil
Your employer
Swiss Paraplegic Research (SPF) is an affiliate of the Swiss Paraplegic Foundation. The mission of SPF is sustainably improving the situation of people with spinal cord injury (SCI) through clinical and interdisciplinary research on a national and international level. Specific areas of its comprehensive research include functioning, movement and mobility, social integration, equality of opportunity, self-determination, quality of life, health services provision as well as morbidity and mortality. SPF is an extra-university research institution recognized and promoted by the Swiss federal government and the cantons and an active link to academic and industrial research and development at the national and international levels.
For our Clinical Trial Unit, we are looking for a
Clinical Quality Specialist 60-70%
For our Clinical Trial Unit, we are looking for a
Clinical Quality Specialist 60-70%
Your responsibility
- 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
Your personality
- 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
Your benefits
- Excellent conditions for innovative, vital- and implementation-oriented research in the context of SCI epidemiology
- A position in a stimulating and productive working atmosphere
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.
Schweizer Paraplegiker-Forschung AG
6207 Nottwil
6207 Nottwil
Contact
Schweizer Paraplegiker-Forschung AG