Du wählst Standorte aus, unterstützt bei der Rekrutierung und evaluierst die Qualität der Praktiken gemäß GCP- und ICH-Richtlinien.
Anforderungen
- •University Degree in life science or scientific discipline
- •Minimum one year on-site monitoring experience
- •Knowledge of GCP and ICH guidelines
- •Strong communication skills and attention to detail
- •Fluency in German at least C1 level
- •Flexibility to travel 40-60% of working time
- •Driver’s license class B
Deine Aufgaben
- •Standorte auswählen und überwachen
- •Entwicklung eines Rekrutierungsplans unterstützen
- •Qualität und Integrität der Standortpraktiken evaluieren
- •Fortschritt bei regulatorischen Einreichungen verfolgen
- •Mit Experten und Kundenvertretern zusammenarbeiten
- •An remote Monitoring und Studienstartprozessen teilnehmen
- •Weniger erfahrene Teammitglieder mentorieren
Deine Vorteile
Ressourcen zur Karriereentwicklung
Flexible Arbeitszeiten durch Führungskräfte
Programme zur therapeutischen Weiterbildung
Dynamische Arbeitsumgebungen für neue Erfahrungen
Home-Office, Firmenwagen und Unfallversicherung
Original Beschreibung
# CRA II (m/w/d), Single Sponsor, home-based Austria
**Vienna, Austria** | **Full time**
Join IQVIA as a **Clinical Research Associate II (m/w/d) home-based throughout Austria** in our **single sponsor department**, and advance your career in clinical research. You’ll enjoy the stability and resources of a leading, global contract research organization while gaining direct experience with one of our clients. Whether you're just starting out or looking to deepen your expertise, this role promises to offer intentional career growth and professional development. With access to world-class training and mentoring, you’ll have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide variety of therapeutic areas.
**Your responsibilities will include:**
* Performing site selection, initiation, monitoring and close-out visits
* Supporting the development of a subject recruitment plan
* Evaluating the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
* Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
* Collaborating with experts at study sites and with client representatives
* Depending on client model there might be remote-monitoring, involvement in study start-up processes, specialization on therapeutic area (pharmaceutical product or medical devices)
* Mentoring of less experienced team members, support as subject matter expert for specific topics or additional tasks might be included
**Qualifications:**
* University Degree in **life science** or other scientific discipline or apprenticeship in the **health care** field
* Minimum of **one****year of on-site monitoring experience**
* Knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
* Strong written and verbal communication skills, attention to detail and ability to work in a fast pace environment
* **Fluency in German** on at least C1 level and a **good command of** **English**
* Flexibility to travel up to 40-60% of working time
* **Driver’s license class B**
**What you can expect:**
* Resources that promote your career growth
* Leaders that support flexible work schedules
* Programs to help you build your therapeutic knowledge
* Dynamic work environments that expose you to new experiences
* Home-office, company car, accident insurance and more
* Monthly gross salary: starting at 4.300 EUR basic - an overpay according to skills and working experience is possible
Whatever your career goals, we are here to ensure you get there!