Senior Clinical Research Associate

Novartis AG; California City (CA); Remote; USD 90.000 - 140.000; Vollzeit

Zusammenfassung

Novartis is seeking a Senior CRA for a field-based and remote opportunity with extensive travel (80%). You will manage and monitor clinical sites for Phase I–IV trials, ensuring compliance with ICH/GCP, FDA/EMEA standards, and internal SOPs.

The role involves on-site and remote monitoring, site initiation, and cross-functional collaboration to drive data quality and trial progress. Candidates should have at least 3 years of site monitoring experience in a scientific/healthcare field, strong

Qualifikationen

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

Aufgaben

• 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.

Kenntnisse

Site monitoring

English fluency

Site management

Jobbeschreibung

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,