Clinical Research Associate
vor 1 Woche
**Beschreibung**:
As a first-tier supplier to our renowned business partner, Roche Diagnostics in Rotkreuz, we are immediately seeking a motivated and dedicated **Clinical Research Associate**for a temporary assignment of one year with the possibility of extension
The Clinical Research Associate will design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies for in vitro diagnostics.
**Tasks**:
- Ensure clinical studies are conducted and documented in accordance with protocols, SOPs, GCP, and applicable regulatory requirements such as FDA, ICH, IVD directives, and Roche policies
- Validate product performance claims and supply high-quality data for regulatory submissions
- Define the clinical and functional utility of investigational products
- Engage with laboratories and key opinion leaders to gather input on investigational products
- Coordinate study activities including site selection, initiation, monitoring, and closeout
- Maintain communication with investigators to ensure timely study execution and resolve discrepancies
- Collaborate with cross-functional teams to support post-launch activities
- Uphold the quality management system and contribute to achieving quality objectives
**Must Haves**:
- Minimum Bachelor degree in science or a related field
- Preferably experience in clinical research or laboratory research
- Minimum of 2 years of relevant clinical or laboratory research experience
- Strong knowledge of GCP, ICH guidelines, and clinical regulatory standards
- Excellent oral and written communication skills in English
- Proficiency in Microsoft Word, Excel, and PowerPoint, along with experience using laptops, iPhones, and iPads
- Ability to work independently, manage time effectively, and maintain sound decision-making
- Experience in a medical laboratory setting and familiarity with clinical protocols is advantageous
**Nice to Haves**:
- Experience in Pathology
**Benefits**:
- Work with modern and modern tools in an innovative working environment
- Experience a work culture that promotes diversity and inclusion and in which all employees feel valued
- Profit from financial support for your professional further training plans
- Take advantage of unbeatable discounts at renowned retailers and over 200 top brands all year round
- Profit from fleet discounts when purchasing new cars or receive constant discounts on fuel with our fuel card
Wir wertschätzen Vielfalt und begrüssen daher alle Bewerbungen - unabhängig von Geschlecht, sozialer Herkunft, Religion, Alter und Identität. Zur leichteren Lesbarkeit und besseren Verständlichkeit verwenden wir nur eine Gender-Form. Selbstverständlich sind im jeweiligen Kontext alle Genderformen gleichermassen gemeint.
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