Clinical Research Associate

1Novartis is first in line when it come to clinical research in Italy. Join an incredible team and help improve patients lives
- The purpose of the Clinical Research Associate is to perform and monitor activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-III of Pharma clinical trials within the country.
- The CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.**Your key responsibilities**:
Your responsibilities include, but are not limited to:
- Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial.
- Be the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries.
- Manages assigned study sites and networks, if applicable, conducting phase I-III protocols according to the monitoring plan and Novartis procedures.
- Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate.
- Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
- Documents monitoring activities appropriately following Novartis standards.
- Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed.
- Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Degree in scientific or healthcare discipline.
- Minimum experience desirable but not necessary, we'll evaluate junior profiles willing to take up a career as a CRA.
- Fluent in both written and spoken English, local language as needed in clusters/countries.
- Good knowledge of drug development process specifically clinical trial/research.
- Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings (a minimum of 50% overnight travel may be required).
- Good communication and presentation skills, negotiation skills and strategic thinking.
- Advanced data accuracy: ability to work focused with a great attention to detail, strong on data and digital.**Why Novartis?**

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- Imagine what you could do here at Novartis**Imagine what you could do at Novartis**

**Division**
- Global Drug Development

**Business Unit**
- GDO GDD

**Country**
- Italy

**Work Location**
- Origgio

**Company/Legal Entity**
- Novartis Farma IT

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No