Study Start-up Clinical Research Associate (Ssu Cra)
- Buenos Aires
- Permanente
- Tiempo completo
Site relationship management role to ensure sustainable trial start-up at Site.
The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.
Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).**Your responsibilities include, but are not limited to**:- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
- Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until site greenlight at assigned sites
- Conducts site selection visits, verifies site eligibility for a specific study. Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
- Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
- Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities
- Supports reduction of formal site-specific IRB/IEC deficiencies**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****Required Experience & Qualifications**:- A degree in scientific or health discipline, preferably with clinical operations experience (or healthcare experience)
- Fluent in both written and spoken English, local language as needed
- Minimum 3 years’ experience in clinical operations in a monitoring / site management role
- Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Central/in-house monitoring or field monitoring experience is desirable
- Strong interpersonal, negotiation and conflict resolution skills;
- Good communication skills, ability to influence others & Relationship management; Trust and rapport building is a very important skill needed
- Fast change adaptability to best partner & influencing with sites on fast changing landscape**Desirable Experience & Qualifications**:- Ability to travel, e.g., for site selections, if applicable
- Ability to manage multiple priorities and manage time efficiently**#GCO****Why Novartis?**
766 million lives were touched by Novartis medicines in 2021, 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!**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.**Join our Novartis Network**:
**Division**Global Drug Development**Business Unit**GCO GDD**Country**Argentina**Work Location**Buenos Aires**Company/Legal Entity**Novartis Argentina S.A**Functional Area**Research & Development**Job Type**Full Time**Employment Type**Regular**Shift Work**No**Early Talent**No
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