portal resources jobs companies n novartis senior clinical research associate

Senior Clinical Research Associate 🔥


Job Description



817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, 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 brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.



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. The Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.



Your Responsibilities



Your responsibilities include, but not limited to



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.



EEO Statement

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.



Minimum Requirements



What you’ll bring to the role



Education Bachelor degree in scientific or healthcare discipline.



Fluency in English.



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.



A minimum of 50% overnight travel may be required.



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.

Division

Global Drug Development

Business Unit

GDO GDD

Country

USA

Work Location

East Hanover, NJ



Company/Legal Entity



Novartis Pharmaceuticals

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

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