Band

Level 3

Job Description Summary

Job Title: Senior Clinical Research Associate (CRA)

#LI-Remote
Primary Location: United States

This role requires the candidates to be living in Texas or Louisianna.

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.

Job Description

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 European regulatory requirements
Ability to manage multiple priorities and work independently
Strong site management, communication, and problem-solving skills
Fluency in written and spoken Czech/Slovak and English
Ability to travel extensively, including both domestic and international

Desirable Requirements

Experience in oncology, including radioligand therapy (RLT) or CAR-T preferred

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 is 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 (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. 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 Eh.occupationalhealth@novartis.com.

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, 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.

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

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, Lifesciences (Inactive)

Senior Clinical Research Associate (Remote)