Senior Clinical Research Associate

Novartis AG

NY

JOB DETAILS
SALARY
$108,500–$201,500 Per Year
SKILLS
Clinical Information Systems, Clinical Monitoring, Clinical Research, Clinical Trial, Corrective Action, Cross-Functional, Customer Relations, Czech Language, Data Quality, Documentation, Driver's License, Drug Development, GCP (Good Clinical Practices), Healthcare, Hospital, ICH Regulations, Legal, Maintain Compliance, Medical Office, Multitasking, Negative Testing, Performance Management, Phase I Clinical Trials, Phase IV Clinical Trials, Problem Solving Skills, Process Improvement, RMON, Regulations, Site Initiation, Slovak Language, Standard Operating Procedures (SOP), Systems Maintenance, Time Management, Training/Teaching, Vaccination, Willing to Travel
LOCATION
NY
POSTED
7 days ago

Job Title: Senior Clinical Research Associate (CRA)#LI-RemotePrimary Location: United StatesCandidates must be located in Georgia, Florida or Tennessee. 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.Key ResponsibilitiesLead assigned sites as the primary point of contact throughout study deliveryBuild strong relationships to ensure site performance, quality, and milestone achievementManage Phase I to Phase IV trials per monitoring plans and company proceduresConduct site initiation visits and deliver ongoing training for site personnelPerform remote and on-site monitoring to ensure compliance and patient safetyMaintain accurate documentation and update all clinical systems in a timely mannerIdentify risks, resolve issues, and escalate concerns as neededCollaborate with cross-functional teams to drive efficient study executionSupport timely data query resolution and ensure data accuracyAct as a subject matter expert across study activities when requiredEssential RequirementsMinimum of three years of clinical site monitoring experienceMinimum of Bachelor's degree in science, healthcare, or a related fieldStrong understanding of clinical research and drug development processesKnowledge of ICH/GCP and European regulatory requirementsAbility to manage multiple priorities and work independentlyStrong site management, communication, and problem-solving skillsFluency in written and spoken Czech/Slovak and EnglishAbility to travel extensively, up to 80% nationallyDesirable RequirementsExperience in radioligand therapy, chimeric antigen receptor T-cell therapy, or oncologyThe 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.

About the Company

N

Novartis AG

Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Biotechnology/Pharmaceuticals
FOUNDED
1996