1!Novartis 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-IV Oncology and 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.
**Responsibilities**:
- 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-IV 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
- Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.
)
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
- Attends onboarding-, disease indication and project specific training and general CRA training as required
- 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**
- Degree in scientific or healthcare discipline.
- Fluent in both written and spoken English, local language as needed in clusters/countries.
- 2 years pharmaceutical industry experience or other relevant experience
- Good knowledge of drug development process specifically clinical trial/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- Monitoring experience is desirable
- 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 skills, ability to influence others.
- Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
- Ability to manage sites independently; Proven ability to work independently with mínimal supervision
- Good strategic thinking
- Ability to anticipate potential issues and take appropriate actions with or without supervision.
- Advanced data accuracy: Ability to work focused with a great attention to detail, strong on data and digital
**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