Sr Clinical Research Associate Cra Ii
hace 5 días
**Job ID
**338590BR
***: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
The Clinical Research Associate ll performs supervising activities related to initiation, conduct (recruitment, quality data collection) and timely completion in different Phases and for different Therapeutic Areas for Oncology and Pharma clinical trials within the country. The CRA ll is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance internal and local regulations;
Your key responsibilities:
- Allocate, initiate and conduct of trials, conducts site selection and recommends potential sites to evaluate their abilities to conduct a clinical trial, performs site Closeout and ensures successful collaboration between the sites and Novartis to meet expectations on landmark and deliveries are met as planned; Identifies issues at sites; resolves issues and raise as appropriate and collaborates with internal partners;
- Performs continuous training for amendments and new site personnel and conducts continuous monitoring activities (onsite and remote) to ensure compliance with protocol, GCP, global and local regulations and processes to secure data integrity and patient safety;
- Documents supervising activities accurately following Novartis standards; Collaborates with the Clinical Research Associates Group Head/Clinical Study Manager to ensure recruitment plans and execute contingency plans, as needed; Performs additional task as assigned Delivery of quality data and compliance to quality standards;
- 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.
**EEO Statement**
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**:
- Life Science, Medical, Health or Scientific Degree or adequate equivalent;
- Sophisticated Spanish and English skills (written, reading and speaking);
- Has +3 years of validated experience in pharmaceutical development, clinical research, and/or supervising clinical trials' understanding of the international aspects of drug development process for different Therapeutic Areas and Phases
- Has the ability to work with different trials at the same time; budget and treatment management;
- Experience identifying new health institutes or CROs and work with the actual ones;
- Build strong relation and arrangements with them;
- Preferably working before in Pharma companies or with Pharma projects;
- Must have knowledge on ICH-GCP, international (i.e. FDA, EMA) and local clinical trials regulations;
- Willing to travel;
- Has excellent abilities to communicate, influence, persuade and negotiate with different teams and partners;
- Has high ethic and integrity skills;
- Looks always for Operational Excellence;
- Has the ability to seek problems and sophisticated issues;
- Has excellent teammate skills.
**Division**
Global Drug Development
**Business Unit**
GDO GDD
**Location**
Argentina
**Site**
Buenos Aires
**Company/Legal Entity**
Novartis Argentina S.A
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
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