Study Start-Up Clinical Research Associate/Specialist (Remote)
Job ID: REQ-10048220
Date: Apr 14, 2025
Location: Remote, USA
Company/Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Job Type: Full Time
Employment Type: Regular
Shift Work: No
Summary:
The Study Start-Up (SSU) CRA/Specialist is responsible for site relationship management to ensure sustainable trial start-up at site level. This role is accountable for site selection as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials, adhering to ICH/GCP, local regulations, and SOPs. Proactive site preparation, early identification of site needs/issues, and smooth handover to the execution CRA are key responsibilities.
This is a remote position based anywhere in the U.S. (some restrictions may apply). Relocation is not provided. Approximately 25% domestic and/or international travel is required.
About the Role:
Your Key Responsibilities:
Support country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager, and SSO Site Partnership Manager.
Collaborate with SSO Study Start-Up Manager, Team Lead, and global study teams to meet Study Start-Up timelines and deliverables according to country commitments.
Conduct site selection visits and verify site eligibility for specific studies.
Serve as the main contact for trial sites during site selection, start-up, and IRB/IEC and HA submission preparation.
Support SSU Manager with country-specific document preparation (e.g., ICFs, patient-facing materials).
Assist sites in vendor setup activities.
Negotiate investigator payments as needed.
Support preparation of financial contracts between Novartis and investigational sites/investigators as needed.
Maintain system updates until site Green Light is achieved.
Ensure timelines, accuracy, and quality of TMF documents during study start-up for TMF inspection readiness.
Ensure adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority, and SOP requirements.
Role Requirements:
Education:
BS/BA Degree required; scientific or healthcare discipline preferred.
Work Experience:
Minimum 3 years of clinical operations experience in a monitoring or site management role.
Advanced understanding of clinical drug development, with emphasis on trial set-up, execution, and monitoring.
Central/in-house or field monitoring experience desirable.
Skills:
Strong site management capabilities with negotiating and problem-solving skills.
Excellent interpersonal, negotiation, and conflict resolution skills.
Ability to manage multiple priorities and time effectively.
Strong communication skills with the ability to influence others.
Relationship management skills including trust and rapport building.
Languages:
Proficiency in English required.
Compensation and Benefits:
Pay range at commencement: $114,100 – $211,900/year.
Compensation may include a sign-on bonus, restricted stock units, discretionary awards, full range of medical/financial/other benefits (including 401(k) eligibility and various paid leaves).
Salary adjustments may occur based on job market factors, location, experience, and skills.
Employees will be in an "at-will" position; compensation programs may be modified based on performance and market factors.
Why Novartis:
Helping people with disease and their families takes more than innovative science — it takes a community of smart, passionate people collaborating, supporting, and inspiring one another to achieve breakthroughs. Ready to create a brighter future together?
Learn more: Novartis People & Culture
Join Our Novartis Network:
Not the right role for you? Stay connected through our Talent Community.
Benefits and Rewards:
Discover how Novartis helps you thrive professionally and personally: Benefits & Rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We are committed to building a diverse and inclusive environment and do not discriminate based on 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 Accommodation:
Novartis provides reasonable accommodation for individuals with disabilities. To request accommodation during the application process or to perform essential job functions, email: us.reasonableaccommodations@novartis.com or call +1(877)395-2339.
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