Senior Clinical Research Associate - Remote- Southeast

255027BR
Senior Clinical Research Associate - Remote- Southeast
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are empowered to ask new questions, make bolder decisions and take smarter risks.

We are Novartis. Join us and help reimagine medicine.

The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.

Trial Monitoring strategy
•Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials
•Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
•Is 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
•Facilitates the preparation and collection of site and country level documents
•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
•Performs additional task as assigned
Delivery of quality data and compliance to quality standards
•Monitors studies as per current legislations, ICH/GCP and Novartis standards
•Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL)
•Identifies issues at sites; resolves issues and escalate as appropriate
•Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
•Ensures the site Investigator Folder is up to date. Is responsible for collecting essential documents from site and accountable to keep sTMF(s) current.
•Participates in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement
•Supports the implementation of innovative processes and technologies
Budget and productivity
•Negotiates investigator remuneration; prepares financial contracts between Novartis and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites

•This position will cover the Southeast territory. Preferred location is Tampa or Orlando, FL.
•Ability to travel within the territory, approximately 50% overnight travel expected.

This is a remote based position
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
The position will be filled at a level Sr. CRA, or Expert CRA) commensurate with experience.
Bachelor’s degree in a scientific or health care discipline required, and advanced degree preferred.

•Minimum of 3 years experience in site monitoring
•Excellent knowledge of the drug development process specifically clinical trial/research
•Knowledge of international standards (GCP/ICH, FDA, EMEA)
•Ability to manage multiple priorities and manage time efficiently.
•Basic project management skills to support in CSM activities.
•Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
•Advanced communication skills, ability to influence others.
•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.
•Ability to manage sites independently; Proven ability to work independently with or without minimal supervision by direct

Additional Requirements for the Expert CRA Level:
• At least four years of proven excellence and experience in all aspects of monitoring and site management.
• Proven proficiency of the drug development process specifically clinical trial/research
• Proven ability to influence and lead others
• Advanced understanding of project management methodology as well as understanding of the structures and roles and responsibilities of personnel working in the GDD organization.
• Excellent site management capabilities with demonstrated negotiating and problem solving skills
• Advanced understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
• Strong communicator and presenter (oral and written)
• Ability to manage multiple priorities and manage time efficiently
• Advanced strategic thinking: Implementation of strategic operational activities with minimal supervision
• Advanced data accuracy: Ability to work focused with a great attention to detail
• Ability to work and manage sites independently; Proven ability to work independently with the expectation of indirectly supervising others

A valid US Driver’s License and a good driving record are required.
Ability to travel within the territory, approximately 50% overnight travel
Global Drug Development
GDO GDD
USA
Tampa, FL
Novartis Pharmaceuticals
Research & Development
Full Time
Regular