Senior Clinical Research Associate
About The Position
This is a field-based and remote opportunity in an assigned geography. The position must be located in the western region of the United States near a major airport, preferably in California. Novartis is unable to offer relocation support. The role requires 80% travel, and driving and air travel are essential functions. A fully valid and unrestricted driver’s license is required. The Senior Clinical Research Associate (internal title: Sr CRA) manages site relationships and conducts on-site and remote monitoring to support the initiation, conduct, and timely completion of Phase I–IV clinical trials. The role ensures compliance with ICH/GCP, local regulations, Standard Operating Procedures, and monitoring procedures, while proactively managing site performance, recruitment, quality, risks, and issues to support sustainable trial execution and high-quality data delivery. The role may be assigned to complex trials and/or less experienced sites and may serve as a subject matter expert. It also supports audit and inspection readiness, timely implementation of corrective actions, and collaboration with local and global cross-functional teams to improve processes and help bring therapies to patients. Eligible US-based employees receive a comprehensive benefits package, performance-based cash incentive, and, depending on role level, may be considered for annual equity awards.
Requirements
- At least 3 years of experience in site monitoring.
- BS/BA degree in a scientific, healthcare, or other related field.
- Excellent knowledge of the drug development process, specifically clinical trials and research.
- Knowledge of international standards, including GCP/ICH, FDA, and EMEA.
- Ability to manage multiple priorities and time efficiently.
- Excellent site management capabilities, with demonstrated negotiating and problem-solving skills.
- Strong oral and written communication and presentation skills.
- Fluency in written and spoken English.
- Fully valid and unrestricted driver’s license.
Nice To Haves
- Experience in cardiology, oncology, CART, RLT, and/or immunology.
Responsibilities
- Serve as the primary site manager and first point of contact between site staff and Novartis.
- Act as a frontline liaison supporting collaboration, milestones, and deliverables.
- Monitor in accordance with applicable legislation, ICH/GCP, and Novartis standards.
- Manage assigned sites and networks conducting Phase I–IV protocols according to monitoring plans and Novartis procedures.
- Conduct site initiation visits and provide ongoing training for site personnel.
- Perform continuous on-site and remote monitoring, ensuring protocol, GCP, regulatory, and process compliance, data integrity, and patient safety.
- Facilitate preparation and collection of site- and country-level documents.
- Identify risks, resolve issues, and escalate concerns as needed.
- Collaborate with cross-functional teams to drive efficient study execution.
- Deliver timely, high-quality, robust, and reliable site data supporting Trial Monitoring goals.
- Partner with the SSU CRA to ensure a seamless transition of site responsibility.
- Act as a subject matter expert across study activities when required.
- Support audit and inspection readiness activities and ensure timely implementation of corrective actions.
- Travel by car and air as required for the role.
Benefits
- Comprehensive health, life, and disability benefits.
- 401(k) with company contribution and match.
- Performance-based cash incentive.
- Depending on role level, eligibility to be considered for annual equity awards.
- Generous time-off package including vacation, personal days, holidays, and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
