Study Start-Up Clinical Research Associate/Specialist (Remote)

Job Description Summary

Multiple Listings

The SSU CRA is a site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.

Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).

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 25% travel

#LI-Remote

 

Job Description

Your Key Responsibilities:

• Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager
• Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
• Conducts site selection visits, verifies site eligibility for a specific study
• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities 
• Negotiates investigator payments as needed
• Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
• Updates all systems until site Green Light on an ongoing basis
• Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
• Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

Role Requirements:

• BS/BA Degree. Degree in scientific or healthcare discipline preferred
• Minimum 3 years’ experience in clinical operations in a monitoring / site management role
• Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
• Central/in-house monitoring or field monitoring experience is desirable
• Strong site management capabilities with demonstrated negotiating and problem-solving skills
• Strong interpersonal, negotiation and conflict resolution skills
• Ability to manage multiple priorities and manage time efficiently
• Good communication skills, ability to influence others & Relationship management, trust and rapport building

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $114,100 and $211,900/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period.  Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factor

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. 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. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

 

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 us.reasonableaccommodations@novartis.com or 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.

 

Salary Range

$114,100.00 - $211,900.00

 

Skills Desired

Budget, Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Analysis, Decision Making Skills, Financial Analysis, Health Sciences, Lifesciences Apply