Summary
Job Title: Senior Clinical Research Associate (Sr. CRA)
#LI-Remote (Field Based)
Primary Location: Florida, United States
Drive clinical trials forward where it matters most - at the site level and with patients at the center. As a Senior CRA at Novartis, you will manage trusted site relationships and perform on-site and remote monitoring activities to support the initiation, conduct, and timely completion of Phase I – IV trials in compliance with International Council for Harmonization / Good Clinical Practices (ICH/GCP), local regulations, Standard Operating Procedures (SOPs), and monitoring procedures. Serving as a key point of contact for investigational sites, you will proactively manage site performance, recruitment, quality, risks, and issue resolution to ensure sustainable trial execution and high-quality data delivery. Assigned to complex trials and/or less experienced sites, you may also act as a Subject Matter Expert, support audit and inspection readiness activities, ensure timely implementation of corrective actions, and collaborate with local and global cross-functional teams to drive process improvements that help bring innovative therapies to patients faster.
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel.
About the Role
Key Responsibilities
- Lead assigned sites as the primary point of contact throughout study delivery
- Build strong relationships to ensure site performance, quality, and milestone achievement
- Manage Phase I to Phase IV trials per monitoring plans and company procedures
- Conduct site initiation visits and deliver ongoing training for site personnel
- Perform remote and on-site monitoring to ensure compliance and patient safety
- Maintain accurate documentation and update all clinical systems in a timely manner
- Identify risks, resolve issues, and escalate concerns as needed
- Collaborate with cross-functional teams to drive efficient study execution
- Support timely data query resolution and ensure data accuracy
- Act as a subject matter expert across study activities when required
Essential Requirements
- Minimum of three years of clinical site monitoring experience
- Minimum of Bachelor’s degree in science, healthcare, or a related field
- Strong understanding of clinical research and drug development processes
- Knowledge of ICH/GCP and 21 CFR regulatory requirements
- Ability to manage multiple priorities and work independently
- Strong site management, communication, and problem-solving skills
- Fluency in English, written and spoken, Spanish highly desired
- Ability to drive and travel extensively, up to 80%, in a company vehicle
Desirable Requirements
- Experience in multiple therapeutic areas and Veeva Vault CTMS is a plus
- Advanced knowledge and use of AI
The salary for this position is expected to range between $108,500 and $201,500 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
