Senior Clinical Research Associate

Novartis AG; Crystal Bay (NV); Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

Disability & life insurance

Job summary

Novartis AG is seeking a Senior CRA for a field-based and remote opportunity across assigned geographies in the United States. You will manage trusted site relationships and perform on-site and remote monitoring to support initiation, conduct, and completion of clinical trials in compliance with ICH/GCP and SOPs.

The role requires 80% travel and collaboration with cross-functional teams. Key responsibilities include monitoring site performance, training, data integrity, and risk management, with

Qualifications

• 3+ years’ experience in site monitoring.
• Strong knowledge of ICH/GCP, FDA and EMEA standards.
• Excellent site management and problem-solving skills.
• Fluent in written and spoken English.

Responsibilities

• Manage assigned sites/networks conducting Phase I–IV protocols per monitoring plans.
• Conduct site initiation visits and training for site personnel.
• Perform continuous on-site/remote monitoring for compliance and patient safety.
• Gather and manage site- and country-level documents.
• Identify risks, escalate issues, and drive corrective actions.
• Deliver high-quality, robust site data to support trial monitoring goals.

Skills

Site monitoring

English proficiency

Regulatory knowledge

Risk management

Education

Science/Healthcare related degree

Job description

Band Level 3 Job Description Summary

#LI-Remote

This is a field-based and remote opportunity in an assigned geography. Novartis is unable to offer relocation support for this role. 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 will require 80% travel. Primary site manager and first point of contact between site staff and Novartis

• Manage assigned sites/networks conducting Phase I–IV protocols according to monitoring plans and Novartis procedures
• Conduct site initiation visits and deliver ongoing training for site personnel
• Continuous on-site/remote monitoring; 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
• Deliver timely, high-quality, robust, reliable site data supporting Trial Monitoring goals
• Partner with SSU CRA for seamless transition of site responsibility

• ~ Minimum of 3 years’ experience in site monitoring
• Scientific, Healthcare or other related field.
• Excellent knowledge of the drug development process specifically clinical trial/research
• Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
• Fluent in both written and spoken English
• Cardiology, Oncology, CART, RLT & Immunology experience a plus!

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

In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

Driving and air travel are an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.

COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions.

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position,