Senior Clinical Research Associate

Novartis Group Companies; United States; A distancia; USD 109.000 - 202.000; Jornada completa

Descripción de la vacante

Novartis Group of Companies in the United States seeks a Senior CRA for field-based and remote monitoring across the western region. The role covers on-site and remote monitoring for Phase I–IV trials, driving site performance, patient safety, and data integrity, with approximately 80% travel.

You will manage site relationships, ensure compliance with ICH/GCP, FDA/EMEA standards, and collaborate with cross-functional teams to enable timely trial execution.

Formación

• Minimum 3 years' experience in site monitoring.
• BS/BA degree in a scientific, healthcare or related field.
• Excellent knowledge of drug development and clinical trial processes (ICH/GCP, FDA).

Responsabilidades

• Serve as primary site manager and point of contact for site staff.
• Monitor according to ICH/GCP, regulations, and internal standards.
• Coordinate site initiation visits and ongoing training.
• Ensure data integrity, patient safety and regulatory compliance.
• Collaborate with cross-functional teams to drive study execution.

Conocimientos

Site management

ICH/GCP knowledge

Communication skills

English fluency

Travel readiness

Educación

BS/BA in life sciences

Herramientas

CTMS

E-clinical systems

Descripción del empleo

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. Please only apply if this location is accessible for you. This position must be located in the western region of the United States near major airport (preferably in California, Washington State, Oregon, Nevada).

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.

Job Description

Key responsibilities

• Primary site manager and first point of contact between site staff and Novartis
• Frontline liaison supporting collaboration, milestones, and deliverables
• Monitor according to legislation, ICH/GCP, and Novartis standards
• 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 escal...
• Collaborate with cross-functional teams to drive efficient study execution
• Deliver timely, high-quality, robust, reliable site data supporting Trial Monitoring goals
• Partner with SSU CRA for seamless transition of site responsibility
• Act as a subject matter expert across study activities when required

Essential Requirements

• Minimum of 3 years' experience in site monitoring
• BS/BA degree. 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)
• Ability to manage multiple priorities and manage time efficiently.
• Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
• Strong communicator and presentation skills (oral and written)
• Fluent in both written and spoken English

Desirable Requirements

• Cardiology, Oncology, CART, RLT & Immunology experience a plus!

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.

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. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. 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

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. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [e-mail].

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 and 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 [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

108,500.00 - 201,500.00

Skills Desired

Clinical Research, Clinical Study Reports, Clinical Trial Management Systems (CTMS), Clinical Trials, Clinical Trials Monitoring, Collaboration, Data Integrity, Decision Making, Life Science